Z-0081-2021Class II

Biomet Regenerex Primary Taper Cap Item Number 141269

Name: Z-0081-2021 Biomet Regenerex Primary Taper Cap Item Number 141269
Creator: Biomet, Inc.
Published: 2020-09-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-09-04 / Terminated / root cause: sterility

FDA source

Biomet, Inc. began a recall of Biomet Regenerex Primary Taper Cap Item Number 141269 on 2020-09-04. FDA classified it as Class II and gives the reason as "Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0081-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-04
Posted: 2020-10-08
Terminated: 2021-08-31
Recalling firm: Zimmer GmbH
Product: Biomet Regenerex Primary Taper Cap Item Number 141269
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Root cause tag: sterility
FDA root cause: Process change control
Action: Zimmer Biomet notified on 9/2/20 Distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory, as well as hospitals that have consumed products in the past 12 months will be notified via FedEx. Surgeons that have consumed products with in the past 12 months notified via FedEx. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you ha
Quantity in commerce: US: 62 units; OUS: 176 units
Distribution: Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
Product codes and lots: Lot Numbers: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0081-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0081-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0082-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0083-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08
Z-0084-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08

Product code MBH

K080361Class IIRegenerex Tibial ComponentsBiomet, Inc. / cleared 2008-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)