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.
Reported: October 29, 2014 Initiated: October 7, 2014 #Z-0123-2015
Product Description
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.
Reason for Recall
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 618 units
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer, Inc.. Units affected: 618 units.
Why was this product recalled? ▼
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2014. Severity: Moderate. Recall number: Z-0123-2015.
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