Reported Oct 29, 2014 · Terminated
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.
- Lot codes and dates
- Part Number 42-5299-001-00 Lots
56572679565731705657291856573378565729755657337956572978565742235657298156574291565729825657429256573071565743165657311556574317565731165657431856573154
- Part Number 42-5299-001-00 Lots
- Amount recalled
- 618 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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