Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1341-2016 — Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18

U.S. FDA — Device Enforcement · United States · 2016-03-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1341-2016
Date of alert
2016-03-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Manufacturing B.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
62632101
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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