—#122553

Product

Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.

FDA product code: GAD — Retractor
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Part J5957AC (old), and Part J5957F (new)

Why it was recalled

The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.

Root cause (FDA determination)

Use error

Action the firm took

Synthes sent an Field Safety Notification letter dated August 1, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following actions: Exchange the old surgical technique guide with the new guide version F provided with this notification. Review the revised surgical technique guide. Forward this Field Safety Notification to anyone in your facility that needs to be informed. If the technique guide has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all technique guides have been exchanged. Maintain a copy of this notice. Please complete and return this page by either of the following methods: Fax: 877-567-9320 or Scan/email: FieldAction@synthes.com Thank you for your attention to this issue.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.

Timeline

Recall initiated: 2013-08-01
Posted by FDA: 2013-11-29
Terminated: 2015-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122553. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.