—#163734

Product

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

FDA product code: GAD — Retractor
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot numbers: T104992, T114599, T140390, T140674, T140675, T140676, T140677, T141539, T143644, T144855, T145296, T145589, T145819, T146660, T147930, T148624, T149725, T149726, T151370, T152806, T152807, T153692, T155648, T156708, T160394, T939640, T987813

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US Nationwide and Canada

Timeline

Recall initiated: 2018-04-02
Terminated: 2019-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163734. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.