FDAClass IIMay 17, 2017

Regenerex Patella RGX 3 PEG SER A Patella 28mm RGX 3 recall

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…

Why was Regenerex Patella RGX 3 PEG SER A Patella 28mm RGX 3 recalled?

pegs shearing post-operatively

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots of Model #'s: 141355 141356 141357 141358

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…
Recalling firm
Zimmer Biomet, Inc.
Quantity
8154
Distribution
US Nationwide.distribution and Canada.
Recall date
May 17, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls