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Terminated

Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

FDA Recall Z-1758-2018 · Posted None

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeGAD
Date Initiated2018-04-02
Date Terminated2019-10-16
Product Quantity235

Reason for Recall

There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.

Firm Action

On April 2, 2018 Synthes (USA) LLC mailed an Urgent Product Recall notification letter to affected customers. Customers were instructed to: Review current inventory to identify and quarantine all affected products; Complete the Verification section of the Return Receipt form; Return affected product; Forward the notification to anyone in your facility that needs to be informed; If affected products have been forwarded to another facility, contact that facility to arrange return; Keep a copy of the notification. Customers with questions may call (610)719-5450 or contact your Depuy Synthese Sales Consultant.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide and Canada

Official Source

View FDA Recall →

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

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