Recall Z-1455-2019— Zimmer GmbH

Class II · Terminated

Class II FDA medical device recall by Zimmer GmbH, initiated 2019-04-08, terminated 2020-05-11. FDA's recall record names no specific 510(k) clearance for this event. Product: CBS micro, countersink, cannulated, round-shaft, Item Number 503004341. 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

Product description

CBS micro, countersink, cannulated, round-shaft, Item Number 503004341

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.