Recall Z-1675-2016— Zimmer Manufacturing B.V.

Name: FDA recall Z-1675-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-04

Class II · Terminated

Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2016-05-04, terminated 2017-07-05. It names one FDA 510(k) clearance: K082527. Product: Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801. Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws..

Recalling firm: Zimmer Manufacturing B.V.
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Terminated: 2017-07-05
Firm location: Mercedita, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K082527 — ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWSZimmer, Inc.·cleared 2008-12-18

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

Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801

Reason for recall

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

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