Recall Z-1341-2016— Zimmer Manufacturing B.V.

Name: FDA recall Z-1341-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-17

Class II · Terminated

Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2016-03-17, terminated 2017-03-14. It names one FDA 510(k) clearance: K113369. Product: 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. 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..

Recalling firm: Zimmer Manufacturing B.V.
Classification: Class II
Status: Terminated
Initiated: 2016-03-17
Terminated: 2017-03-14
Firm location: Mercedita, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K113369 — ZIMMER PERSONA KNEE SYSTEMZimmer, Inc.·cleared 2012-03-27

K-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

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.