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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 6 of 10

Device	Model / Reference	Registries	Class	Status
Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate Narrow	K132704	FDA 510(k)	Class II	Active
20-Hole Adaptation Plate	K981070	FDA 510(k)	Class II	Active
Comprehensive Humeral Fracture Positioning Sleeve	K033506	FDA 510(k)	Class II	Active
Recovery Protrusio Cage	K971890	FDA 510(k)	Class II	Active
Patient Matched Titanium Alloy Trochlea	K001350	FDA 510(k)	Class II	Active
Texas T - Plate	K031334	FDA 510(k)	Class II	Active
Integral Total Hip System	K921225	FDA 510(k)	Class II	Active
150mm Cocr Bimetric Head/Neck Replacement Hip Stem- Color Buff Finish	K983710	FDA 510(k)	Class II	Active
M.a.r.a. (modular Acetabular Reconstruction Syst)	K911718	FDA 510(k)	Class II	Active
Ascent Knee System	K011219	FDA 510(k)	Class II	Active
Compress and Mini Compress Anti-Rotation Spindles	K183553	FDA 510(k)	Class II	Active
Poly-Medics Heat Pack	K941245	FDA 510(k)	Class I	Active
Cement Ring	K813089	FDA 510(k)	Class II	Active
Affixus Tibial Nailing System	K150867	FDA 510(k)	Class II	Active
StageOne™ Shoulder Cement Spacer Molds	K221968	FDA 510(k)	Class II	Active
Regenerex Tibial Components	K080361	FDA 510(k)	Class II	Active
Bed Board	K780230	FDA 510(k)	Class I	Active
Avl Hinge Knee System	K051570	FDA 510(k)	Class II	Active
Discovery-Mosaic Total Humerus System	K043505	FDA 510(k)	Class II	Active
Vanguard Anterior Stabilized Tibial Bearings	K050222	FDA 510(k)	Class II	Active
Biomet Oncology Salvage System (oss) Taper Stacking Adapter	K011455	FDA 510(k)	Class II	Active
Bio-Modular Shoulder System With Hydroxyapatite (ha) Coated Glenoid Components	K043100	FDA 510(k)	Class II	Active
Titanium Femoral Component	K981996	FDA 510(k)	Class II	Active
Lactosorb Panels And Fasteners	K980927	FDA 510(k)	Class II	Active
Rc Buttress	K991009	FDA 510(k)	Class II	Active
Zirconia 22.22mm Ceramic Modular Heads	K991708	FDA 510(k)	Class II	Active
Ascent System	K982869	FDA 510(k)	Class II	Active
Ringloc Bi-Polar Acetabular Component	K051569	FDA 510(k)	Class II	Active
Arthrotek Resorbable No-Profile Lactosorb L-15 Screw & Washer	K021832	FDA 510(k)	Class II	Active
Ringloc Constrained Liners Ii	K021728	FDA 510(k)	Class II	Active
Generation 4 Bone Cement	K993836	FDA 510(k)	Class II	Active
Titanium Pediatric Femoral Nail	K993956	FDA 510(k)	Class II	Active
2.5 Mm Lactosorb Screws	K981666	FDA 510(k)	Class II	Active
Mimix Mp Bone Void Filler	K043280	FDA 510(k)	Class II	Active
Palacos R Bone Cement With Gentamicin	K030086	FDA 510(k)	Class II	Active
Dosimetry Release Of Radiation Steril.	K823059	FDA 510(k)	N/A	Active
Abdominal Belt	K780229	FDA 510(k)	Class I	Active
Anatomic Total Knee Prosthesis	K000978	FDA 510(k)	Class II	Active
Cement-On Femoral Stem	K963709	FDA 510(k)	Class II	Active
Porous Apf/Modular Femoral Component	K852585	FDA 510(k)	Class II	Active
Lactosorb Hand System	K991763	FDA 510(k)	Class II	Active
Mini-Fixator For Colles Fractures	K982982	FDA 510(k)	Class II	Active
New Bio-Moore Endo Head, Taper Adapter	K002106	FDA 510(k)	Class II	Active
Bi-Metric Ccocr Head/Neck Replacement System	K992058	FDA 510(k)	Class II	Active
Surface Replacement Hip Prosthesis	K811718	FDA 510(k)	Class I	Active
Lactosorb Push Screw	K002423	FDA 510(k)	Class II	Active
Samarco Spider Plates	K001271	FDA 510(k)	Class II	Active
Soft Tissue Screw And Washer	K012572	FDA 510(k)	Class II	Active
36mm Biolox Delta Ceramic Heads	K061312	FDA 510(k)	Class II	Active
X-Series Integral Lateralized Hip Components	K030501	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