Recall Z-1448-2019— Zimmer GmbH

Name: FDA recall Z-1448-2019
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: K152312. Product: V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637. 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

K152312 — RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH·cleared 2015-10-30

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

V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637

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.