Recall Z-2091-2013— Zimmer, Inc.

Name: FDA recall Z-2091-2013
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 Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). 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 Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). 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.