Persona The Personalized Knee System Articular Surface Posterior… — Class II medical device recall Z-1340-2016
Terminated recall by Zimmer Manufacturing B.V., reported 2016-04-13, distributed in AL, AZ, CA, GA, HI, ID, KS, LA…. The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)informatio
| Recall number | Z-1340-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Manufacturing B.V., Mercedita, PR, United States |
| Recall initiated | 2016-03-17 |
| Classified | 2016-04-06 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-03-14 |
| Distributed | AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, WI |
| Countries outside the US | AT, DE, ES, IT, JP, KR, SG, ZA |
| Lot numbers | 62646580 |
| Model numbers | 42-5114-005-14 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1340-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.