—#142701

Product

Synthes Small Electric Drive (SED). For use in general traumatology.

FDA product code: HTC — Pliers, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: All Lots

Why it was recalled

The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 11/13/2014 DePuy Synthes send a letter to all their customers informing them of the recall of all the lots of the Small Electric Drive (SED) with instructions to returned and possible exchange. Contact is Complaint Handling Unit Manager at 561-494-3673

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA and HI, and the countries of Germany, Hong Kong, Chile, Israel, Poland, Italy, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, Netherlands, France, Japan, Sweden, Switzerland, Austria, China, India, Thailand, Russia, New Zealand, Zaire, Australia, Taiwan, and Malaysia.

Timeline

Recall initiated: 2014-08-14
Posted by FDA: 2016-02-03
Terminated: 2016-02-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142701. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.