Z-2068-2017Class II

Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX...

Name: Z-2068-2017 Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX...
Creator: Zimmer Biomet, Inc.
Published: 2017-03-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-03-22 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The... on 2017-03-22. FDA classified it as Class II and gives the reason as "pegs shearing post-operatively". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2068-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-22
Posted: 2017-04-25
Terminated: 2017-10-03
Recalling firm: Zimmer GmbH
Product: Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: pegs shearing post-operatively
FDA root cause: Under Investigation by firm
Action: On 3/22/2017 URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributors, Sales Representatives, and Distributor Operation Managers Your Responsibilities 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. a. Request a Return Authorization Number via email to [email protected] or through FAST/SMS. Be sure to specify RECALL as the RGA type when requesting. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. 5. Note that any hospitals and surgeons that received direct shipments of this product from Zimmer Biomet or were consigned products, will be sent a copy of the Risk Manager and Surgeon Field Action Notice directly. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals and/or surgeons that may hav
Quantity in commerce: 8154
Distribution: US Nationwide.distribution and Canada.
Product codes and lots: All lots of Model #'s: 141355 141356 141357 141358

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2068-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2068-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-10

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)