Recall Z-1525-2018— Zimmer GmbH

Name: FDA recall Z-1525-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-28

Class II · Terminated

Class II FDA medical device recall by Zimmer GmbH, initiated 2018-02-28, terminated 2019-10-25. It names one FDA 510(k) clearance: K123392. Product: Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496. Reason: A potential commingle that could result in the product in the package not matching the product on the outer label..

Recalling firm: Zimmer GmbH
Classification: Class II
Status: Terminated
Initiated: 2018-02-28
Terminated: 2019-10-25
Firm location: Winterthur, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K123392 — AVENIR MULLER STEMZimmer GmbH·cleared 2013-03-04

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

Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496

Reason for recall

A potential commingle that could result in the product in the package not matching the product on the outer label.

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