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Terminated

Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.

FDA Recall Z-0991-2009 · Posted 2009-02-27

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-12-19
Date Terminated2009-12-22
Product Quantity1,461 of both products.

Reason for Recall

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

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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