Recall Z-2090-2013— Zimmer, Inc.

Name: FDA recall Z-2090-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-19

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-06-19, terminated 2015-06-16. It names one FDA 510(k) clearance: K830196. Product: Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.. Reason: Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-19
Terminated: 2015-06-16
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K830196 — CORSTREN COMPRESSION TUBE & PLATEZimmer, Inc.·cleared 1983-03-25

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

Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.

Reason for recall

Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.

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