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Biomet, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 56 E Bell Dr, WARSAW, IN, 46581
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1825034
DUNS Number: —

Catalogue (471)

Page 3 of 10

Device	Model / Reference	Registries	Class	Status
Reduced Size Oncology Salvage System	K021260	FDA 510(k)	Class II	Active
Proximal Humeral Replacement System	K925613	FDA 510(k)	Class II	Active
Bone Mulch Screw	K941941	FDA 510(k)	Class II	Active
Custom Flanged Acetabular Component	K983035	FDA 510(k)	Class II	Active
2mm Pediatric Flex Nail	K022531	FDA 510(k)	Class II	Active
Dhs Disposable Hood System	K021992	FDA 510(k)	Class II	Active
Vanguard Knee System Titanium Femoral Components	K080204	FDA 510(k)	Class II	Active
Taperloc 12/14 Taper Femoral Components	K043537	FDA 510(k)	Class II	Active
Biolox Delta Ceramic Heads	K042091	FDA 510(k)	Class II	Active
Maxim Knee System	K993159	FDA 510(k)	Class II	Active
Abc Total Elbow Prothesis	K972691	FDA 510(k)	Class II	Active
Compress Distal Femoral Replacement System	K041352	FDA 510(k)	Class II	Active
Titanium Muller Total Hip	K780357	FDA 510(k)	Class II	Active
Healey Revision Component System	K921139	FDA 510(k)	Class III	Active
Explor Modular Radial Head Replacement Device	K051385	FDA 510(k)	Class II	Active
Biomet Bi-Polar Shoulder System	K002998	FDA 510(k)	Class II	Active
Lactosorb Bone Pin	K990291	FDA 510(k)	Class II	Active
Ascent Knee System	K002678	FDA 510(k)	Class II	Active
Biomet Modular Femoral Revision System	K090757	FDA 510(k)	Class III	Active
Compress Segmental Femoral Replacement System	K043547	FDA 510(k)	Class III	Active
Biomet External Wrist Plate	K003240	FDA 510(k)	Class II	Active
Pccs Graft Delivery System	K021071	FDA 510(k)	Class II	Active
Lorenz Mandibular Distractor	K955640	FDA 510(k)	Class II	Active
Bmp Cable System	K982545	FDA 510(k)	Class II	Active
Bandage Spreader Block	K780227	FDA 510(k)	Class I	Active
X-Series Bi-Metric Hip Femoral Components	K020580	FDA 510(k)	Class II	Active
StageOne™ Select Hip Cement Spacer Molds	K222760	FDA 510(k)	Class II	Active
Mallory/Head Total Hip System	K853259	FDA 510(k)	Class II	Active
Modification To Oncology Salvage System (oss)	K020970	FDA 510(k)	Class II	Active
Affixus Hip Fracture Nail	K183162	FDA 510(k)	Class II	Active
Vanguard 360 Revision Knee System	K093293	FDA 510(k)	Class II	Active
Signature Personalized Patient Care System - Glenoid Guide System	K130126	FDA 510(k)	Class II	Active
Vasovasostomy Stabilizer Platform Dev	K811223	FDA 510(k)	Class I	Active
M2a Acetabular System	K011110	FDA 510(k)	Class III	Active
Bio-Modular Shoulder System	K992119	FDA 510(k)	Class II	Active
Tronzo Hip	K812946	FDA 510(k)	Class II	Active
Bandage, Elastic	K780231	FDA 510(k)	Class I	Active
Vanguard Xp Femoral Component(gen Ii)/Vanguard Xp Femoral Trial	K141407	FDA 510(k)	Class II	Active
Gps Platelet Separation Kit With Anticoagulant Acd-A	K030555	FDA 510(k)	Class I	Active
Harpoon Suture Anchor	K926037	FDA 510(k)	Class II	Active
Ringloc Constrained Liner	K950202	FDA 510(k)	Class II	Active
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws	K193214	FDA 510(k)	Class II	Active
Modular Protusio Cup	K990032	FDA 510(k)	Class II	Active
Maxim Removable Molded Poly Tibia	K991753	FDA 510(k)	Class II	Active
Ascent Knee System	K991428	FDA 510(k)	Class II	Active
Biomet Variable Pitch Compression Screw System	K160058	FDA 510(k)	Class II	Active
Cocr Bi-Angular Humeral Component	K961571	FDA 510(k)	Class II	Active
Agc V2 Revision Knee System	K984054	FDA 510(k)	Class II	Active
G7 Freedom and Offset Liners, Freedom Head, Size 32	K142882	FDA 510(k)	Class II	Active
Atlas Fracture Proximal Humeral Nail	K971816	FDA 510(k)	Class II	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 23, 2025	Z-0212-2026	—	open, classified	There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Sep 9, 2025	Z-2619-2025	—	open, classified	The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Oct 21, 2024	Z-0477-2025	—	open, classified	Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
May 17, 2024	Z-2179-2024	—	open, classified	41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
Mar 13, 2024	Z-1607-2024	—	open, classified	Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Nov 2, 2023	Z-0570-2024	—	open, classified	One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Nov 2, 2023	Z-0569-2024	—	open, classified	One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Oct 9, 2023	Z-0382-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0386-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0381-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0374-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0370-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0380-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0377-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0373-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0371-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0388-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0378-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0375-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0387-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0385-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0376-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0372-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0379-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0383-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0384-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Feb 6, 2023	Z-1284-2023	—	open, classified	The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
Dec 29, 2022	Z-1043-2023	—	open, classified	Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Dec 29, 2022	Z-1042-2023	—	open, classified	Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Dec 15, 2022	Z-1018-2023	—	open, classified	Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Nov 29, 2022	Z-1036-2023	—	open, classified	Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Feb 14, 2022	Z-0811-2022	—	terminated	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Feb 14, 2022	Z-0812-2022	—	terminated	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Feb 14, 2022	Z-0810-2022	—	terminated	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Feb 14, 2022	Z-0809-2022	—	terminated	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Jan 7, 2022	Z-0677-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0673-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0670-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0674-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0675-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0672-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0671-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0676-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jun 2, 2021	Z-2270-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2268-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2266-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2274-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2265-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2260-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2267-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2271-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2261-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2259-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2264-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2273-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2262-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2275-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2269-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2272-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2263-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jan 15, 2021	Z-1131-2021	—	terminated	Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Dec 23, 2020	Z-0882-2021	—	terminated	The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
Dec 1, 2020	Z-0723-2021	—	terminated	Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
Nov 25, 2020	Z-0616-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0619-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0620-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0617-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0631-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0621-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0627-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0624-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0630-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0626-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0625-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0623-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0629-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0618-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0628-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0622-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Sep 4, 2020	Z-0081-2021	—	terminated	Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Sep 4, 2020	Z-0083-2021	—	terminated	Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Sep 4, 2020	Z-0082-2021	—	terminated	Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Sep 4, 2020	Z-0084-2021	—	terminated	Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Sep 3, 2020	Z-0097-2021	—	terminated	Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
Sep 2, 2020	Z-0093-2021	—	terminated	Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
May 14, 2020	Z-2311-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2313-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2312-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2316-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2315-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2322-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2310-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2323-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2317-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2321-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2319-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2324-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2308-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2304-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2320-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities