Recall Z-0449-2016— Zimmer Manufacturing B.V.

Name: FDA recall Z-0449-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-02

Class II · Terminated

Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2015-12-02, terminated 2016-09-16. It names one FDA 510(k) clearance: K933785. Product: Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.. Reason: Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264.

Recalling firm: Zimmer Manufacturing B.V.
Classification: Class II
Status: Terminated
Initiated: 2015-12-02
Terminated: 2016-09-16
Firm location: Mercedita, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K933785 — NEXT GENERATION KNEE SYSTEMZimmer, Inc.·cleared 1995-01-30

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

Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.

Reason for recall

Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264

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