Synthes Small Electric Drive (SED). For use in general traumatology.
FDA device recall Z-0747-2016 · posted 2016-02-03 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HTC
- Quantity affected
- 599 each
- Distribution
- 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,
- Date initiated
- 2014-08-14
- Date posted
- 2016-02-03
- Date terminated
- 2016-02-05
- Location
- Palm Beach Gardens, FL
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