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Terminated

Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.

FDA Recall Z-2418-2015 · Posted 2015-08-19

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeGAD
Date Initiated2015-07-29
Date Terminated2016-05-19
Product Quantity1113

Reason for Recall

Potential for micropores to form, allowing fluid to enter the hollow handle.

Firm Action

Urgent recall letters, dated July 29,2015, were sent to end users and sales consultants to inform them of the issue, potential risks, and to provide instructions for returning affected devices and the response form.

Root Cause

Process control

Distribution Pattern

Nationwide and internationally, including Canada

Official Source

View FDA Recall →

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

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