Recall Z-2092-2013— Zimmer, Inc.

Name: FDA recall Z-2092-2013
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: VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. 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

VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. 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.