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Terminated

Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)

FDA Recall Z-2226-2014 · Posted 2014-08-14

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-07-23
Date Terminated2015-09-15
Product Quantity412 units

Reason for Recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Firm Action

On July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall. Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

Official Source

View FDA Recall →

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

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