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Terminated

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

FDA Recall Z-0747-2016 · Posted 2016-02-03

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHTC
Date Initiated2014-08-14
Date Terminated2016-02-05
Product Quantity599 each

Reason for Recall

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

Firm Action

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

Root Cause

Nonconforming Material/Component

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.

Official Source

View FDA Recall →

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

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