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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 9 of 10

Device	Model / Reference	Registries	Class	Status
Distal Radius Plating System	K020819	FDA 510(k)	Class II	Active
Calcium Phosphate Granular Bone Void Filler	K011531	FDA 510(k)	Class II	Active
Iss Offset Heads	K003428	FDA 510(k)	Class II	Active
M2a 32mm Taper System	K003363	FDA 510(k)	Class II	Active
Pennsylvania Hospital Hip Sys	K841437	FDA 510(k)	Class II	Active
ALLthread PEEK Suture Anchor	K193402	FDA 510(k)	Class II	Active
G7 Dual Mobility System, Active Articulation System	K161190	FDA 510(k)	Class II	Active
Cannulated Arthrorivet And Cannulated Rc Arthrorivet	K033519	FDA 510(k)	Class II	Active
130 Modified Integral Femoral Component	K984408	FDA 510(k)	Class II	Active
Pmi Hip Femoral	K923452	FDA 510(k)	Class II	Active
Orthosorb Ls	K140625	FDA 510(k)	Class II	Active
M2a 28mm Ringloc Liner	K002379	FDA 510(k)	Class III	Active
Craniofacial Anchors	K974136	FDA 510(k)	Class II	Active
Craniofacial Calcium Phosphate Ceramic Bone Filler	K990290	FDA 510(k)	Class II	Active
Titanium Low Profile Screws	K991807	FDA 510(k)	Class II	Active
Agc And Maxim Knee Components With Nts	K922285	FDA 510(k)	Class II	Active
Lactosorb Tibial L-15 Screw And Washer	K033233	FDA 510(k)	Class II	Active
Kirschner Sholders With Titanium Plasma Spray	K961260	FDA 510(k)	Class II	Active
Echo Bi-Metric Microplasty Line Extension	K150503	FDA 510(k)	Class II	Active
Integrated Endoscopy System 1000	K920800	FDA 510(k)	Class II	Active
Bipolar Shoulder Prosthesis	K991585	FDA 510(k)	Class II	Active
Finn Knee System	K945028	FDA 510(k)	Class II	Active
Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped	K984209	FDA 510(k)	Class II	Active
Regenerx Ringloc + Modular Acetabular Shells	K070369	FDA 510(k)	Class II	Active
M2a Magnum System	K042037	FDA 510(k)	Class III	Active
Dosimetry Release Of Radiation Steriliz	K831512	FDA 510(k)	Class II	Active
Biolox Delta Ceramic Option Heads	K141653	FDA 510(k)	Class II	Active
Femoral Cement Restrictor	K800144	FDA 510(k)	Class II	Active
Ranawat/Burstein Porous Total Hip Femoral Comp	K911685	FDA 510(k)	Class II	Active
Orthosises Devices	K780225	FDA 510(k)	Class I	Active
Collarless Tapered Stem Hip Prosth. Dev	K811738	FDA 510(k)	Class II	Active
Vanguard M Series Unicondylar Tibial Bearings	K042093	FDA 510(k)	Class II	Active
Mallory/Head Modular Calcar With And Without Ha	K031693	FDA 510(k)	Class II	Active
Im Total Femur	K033871	FDA 510(k)	Class II	Active
Cut Resistant Glove Liner	K902633	FDA 510(k)	Class I	Active
Peri-Prosthetic Cable System	K133354	FDA 510(k)	Class II	Active
Hap Bio-Groove Total Hip Prosthesis (bio-Coat)	K912369	FDA 510(k)	Class II	Active
Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known	K033489	FDA 510(k)	Class II	Active
Generation 4 Polished Femoral Hip Prosthesis	K031734	FDA 510(k)	Class II	Active
Harpoon Suture Anchors	K973775	FDA 510(k)	Class II	Active
Refobacin Bone Cement R	K150850	FDA 510(k)	Class II	Active
Worland Unicondylar Tibial Bearing	K011795	FDA 510(k)	Class II	Active
Agc Revision Knee Prothesis	K912245	FDA 510(k)	Class II	Active
Gross Femoral Component	K001580	FDA 510(k)	Class II	Active
Arthrotek Set Screw	K932721	FDA 510(k)	Class II	Active
Orthopedic Devices	K780235	FDA 510(k)	Class II	Active
Maxim Accel (vanguard) Ps+ Bearings	K041046	FDA 510(k)	Class II	Active
Oss Les Proximal Femoral Component	K021380	FDA 510(k)	Class II	Active
Lactosorb Trauma Plating System	K971870	FDA 510(k)	Class II	Active
Reinforced Hip Cup	K810120	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