Zimmer Reconstruction System Offset Clamp Tips 4.5 cm Offset, Item # 00-1179-028-03, Zimmer Inc., Warsaw, IN. Intended t

FDA device recall Z-0501-2011 · posted 2010-12-01 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.

Action taken

Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall. Locate all instruments and quarantine them immediately. Count all affected product in their territory and record the data on the Inventory Return Certification Form included with the letter. Fax a copy of the completed Inventory Return Form to: Zimmer, Inc. at (574) 372-4265. Return the recalled product along with the original completed Inventory Return Certification Form to: Zimmer Distribution Center Attn: Product Service 1777 West Center Street Warsaw, IN 46580 For questions customers were instructed to contact their Zimmer Sales Representative. For questions regarding this recall call 1 - (800) 613-6131.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HWN

Quantity affected

217 all products

Distribution

Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South Americ

Date initiated

2010-02-16

Date posted

2010-12-01

Date terminated

2011-10-05

Location

Warsaw, IN