FDA Device recall Z-0123-2015
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures
- FDA Device
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 the FDA classified a Class II recall of The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures by Zimmer, citing affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0123-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-07 |
| Published | 2014-10-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
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.
Identifiers
| code_info | Part Number 42-5299-001-00 Lots: 56572679; 56573170; 56572918; 56573378; 56572975; 56573379; 56572978; 56574223; 5…Part Number 42-5299-001-00 Lots: 56572679; 56573170; 56572918; 56573378; 56572975; 56573379; 56572978; 56574223; 56572981; 56574291; 56572982; 56574292; 56573071; 56574316; 56573115; 56574317; 56573116; 56574318; 56573154. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0123-2015%22
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