Z-2146-2020Class II

Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM

Name: Z-2146-2020 Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM
Creator: Biomet, Inc.
Published: 2020-04-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-04-17 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis on 2020-04-17. FDA classified it as Class II and gives the reason as "Potential presence of elevated endotoxin levels that exceed the specification limit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2146-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-17
Posted: 2020-05-28
Terminated: 2021-06-25
Recalling firm: Zimmer GmbH
Product: Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Potential presence of elevated endotoxin levels that exceed the specification limit
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet issued Urgent Medical Device recall letter dated April 17, 2002 to distributors with direct sales and/or field inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory, as well as hospitals that have consumed products will be notified via FedEx. Surgeons that have consumed products will be notified via FedEx. Action to take: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. This form must be returned even if you do not have affected products available to return in your territory. b. For international returns, request an IRA by emailing [email protected] c. For each return, send a copy of Attachment 1 to [email protected]. CF04107 Rev. 4, Eff. Date: 16 Jul 2019 Ref. CP04102 Field Action Activities d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or i
Quantity in commerce: 15 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.
Product codes and lots: Lot Numbers: UDI Number 1) 561760 (01)00880304554412(17)211229(10)561760; 2) 091090 (01)00880304506084(17)211214(10)091090

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2146-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2144-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2145-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2146-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2147-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2148-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2149-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2150-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2151-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2152-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2153-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2154-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2155-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2156-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28

Product code MBH

K083782Class IIRegenerex Patella ComponentsBiomet Manufacturing Corp / cleared 2009-04-03

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)