Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-03

FDA device recall Z-0991-2009 · posted 2009-02-27 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

The c-clip located near the connection end may fracture or fall off during use in surgical procedures.

Action taken

U.S. consignees were notified by "Urgent: Device Recall" letter issued via e-mail on December 19, 2008. The letter described the problem and instructed customers to immediately quarantine and return the recalled product along with the completed Inventory Return Certification form to the Zimmer, Inc. Distribution Center. Consignees were also instructed to fax a copy of the completed Inventory Return Certification Form at 1-574-371-8603. International consignees were also notified, but Zimmer, Inc. will gather the instruments from those customers. Direct questions about the recall to Zimmer, Inc. at 1-800-613-6131.

Root cause

Labeling design

Status

Terminated

Product code

LXH

Quantity affected

1,461 of both products.

Distribution

Worldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom.

Date initiated

2008-12-19

Date posted

2009-02-27

Date terminated

2009-12-22

Location

Warsaw, IN