Recall Z-0123-2015— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2014-10-07, terminated 2015-09-23. It names one FDA 510(k) clearance: K113369. Product: 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: Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-07
- Terminated
- 2015-09-23
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.