Recall Z-1451-2019— Zimmer GmbH

Name: FDA recall Z-1451-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-08

Class II · Terminated

Class II FDA medical device recall by Zimmer GmbH, initiated 2019-04-08, terminated 2020-05-11. It names one FDA 510(k) clearance: K123347. Product: Drill, 3.2x145mm, AO, Item Number 502015650. Reason: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications..

Recalling firm: Zimmer GmbH
Classification: Class II
Status: Terminated
Initiated: 2019-04-08
Terminated: 2020-05-11
Firm location: Winterthur, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K123347 — NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0Normed Medizin-Technik GmbH·cleared 2013-08-02

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

Drill, 3.2x145mm, AO, Item Number 502015650

Reason for recall

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

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