Recall Z-1008-2014— Zimmer, Inc.

Name: FDA recall Z-1008-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-11

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-10-11, terminated 2017-04-14. It names 2 FDA 510(k) clearances: K965098, K962561. Product: RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.. Reason: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-11
Terminated: 2017-04-14
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K965098 — INTRAMEDULLARY NAIL SYSTEMZimmer, Inc.·cleared 1997-02-28
K962561 — SUPRACONDYLAR INTRAMEDULLARY NAILZimmer, Inc.·cleared 1996-09-25

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

RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.

Reason for recall

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

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