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Biomet, Inc.

Last updated September 17, 2026

Information

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

Catalogue (471)

Page 2 of 10

Device	Model / Reference	Registries	Class	Status
Lactosorb Sheets	K992158	FDA 510(k)	Class II	Active
Platform Tcck Total Knee	K790762	FDA 510(k)	Class II	Active
Maxim Accel Knee System	K023546	FDA 510(k)	Class II	Active
Zirconia Ceramic Modular Heads (norton Advanced Ceramics)	K964431	FDA 510(k)	Class II	Active
Arcom Polyethylene Acetabular Liners & Components	K926107	FDA 510(k)	Class II	Active
Biomet Modular Total Hip Femoral Components	K912712	FDA 510(k)	Class II	Active
Bio-Modular Shoulder Offset Humeral Heads	K992899	FDA 510(k)	Class II	Active
Fine Grain Cast Cobalt Chromium Hip Stems	K953925	FDA 510(k)	Class II	Active
Recap Ha Press-Fit Femoral Resurfacing Head	K071053	FDA 510(k)	Class II	Active
Brooker Bio-Groove Femoral Component	K864085	FDA 510(k)	Class II	Active
Konstruct Patellar Component	K960856	FDA 510(k)	Class II	Active
Biomet Metal-On-Metal Hip Systems- Expanded Contraindications	K082446	FDA 510(k)	Class III	Active
Tsp Hip Fracture Plating System	K140018	FDA 510(k)	Class II	Active
Ascent Xxl Closed Box Femoral Component	K002772	FDA 510(k)	Class II	Active
Avl Hinge Knee System	K010774	FDA 510(k)	Class II	Active
Arthtotek Precision Hand Instrumentation	K933070	FDA 510(k)	Class II	Active
Traction Units	K780228	FDA 510(k)	Class I	Active
Cobalt Bone Cement	K051496	FDA 510(k)	Class II	Active
Acumen Surgical Navigation System	K031454	FDA 510(k)	Class II	Active
Apf Porous Coated Line Extension	K984154	FDA 510(k)	Class II	Active
Maxim Removable Molded Poly Tibia	K984623	FDA 510(k)	Class II	Active
Total Toe System	K920446	FDA 510(k)	U	Active
Porous Apf/Collarless Modular Femoral Component	K852584	FDA 510(k)	Class II	Active
Bipolar Shoulder Prosthesis-Shell(rd-113130/33, Biangular Modular Head(rd-113101/41/42, Biomodular Modular Head(rd-113143	K960363	FDA 510(k)	Class III	Active
Ultra-Drive 3	K031280	FDA 510(k)	Class II	Active
Bio-Modular Shoulder System	K030710	FDA 510(k)	Class II	Active
Biomet Tibial trays	K142933	FDA 510(k)	Class II	Active
Lactosorb Screw Anchor	K003273	FDA 510(k)	Class II	Active
Advantage Mapf Hip Femoral Component	K960643	FDA 510(k)	Class II	Active
Membrane Tack	K981459	FDA 510(k)	Class II	Active
Modified Distal Radius Plating System	K133939	FDA 510(k)	Class II	Active
Mallory-Head Modular Calcar Stems With Interlocking Slots	K042774	FDA 510(k)	Class II	Active
Lactosorb Trauma Plating System	K992355	FDA 510(k)	Class II	Active
Disposable Infusion Pump Kit	K993972	FDA 510(k)	Class II	Active
Pavlik Harness	K780375	FDA 510(k)	Class I	Active
Impact Co-Cr 1-Piece Femoral Component	K942027	FDA 510(k)	Class II	Active
Lorenz Lactosorb Vocal Medialization Implant	K011554	FDA 510(k)	Class II	Active
Performance Knee System	K992167	FDA 510(k)	Class II	Active
Bone Mulch Screw System	K991298	FDA 510(k)	Class II	Active
Biomet Sports Medicine Juggerknot Soft Anchor	K110145	FDA 510(k)	Class II	Active
Fixed Bearing Uni Component	K021621	FDA 510(k)	Class II	Active
Portrait Femoral Component	K010560	FDA 510(k)	Class II	Active
Biomet Bone Screw	K964970	FDA 510(k)	Class II	Active
Agc Unicompartmental Knee Prosthesis	K873601	FDA 510(k)	Class II	Active
Lorenz Lactosorb Panels And Fasteners	K011139	FDA 510(k)	Class II	Active
Color Buffed Cemented Femoral	K992903	FDA 510(k)	Class II	Active
Bi-Angular Shoulder System	K032895	FDA 510(k)	Class II	Active
Ha X-Series Bi-Metric Hip Femoral Components	K023409	FDA 510(k)	Class II	Active
Comprehensive Reverse Shoulder - E1 Polyethylene Claims	K121183	FDA 510(k)	Class II	Active
Traction Belt, Pelvic	K780234	FDA 510(k)	Class I	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