FDA Device recall Z-1340-2016
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile
- FDA Device
- Class II
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class II recall of Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile by Zimmer Manufacturing B V, citing the firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-00….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1340-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-17 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Manufacturing B V |
| Distribution | AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, WI |
Product
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
Reason
The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
Identifiers
| code_info | lot 62646580 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V
All Zimmer Manufacturing B V recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1340-2016%22
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