Recall Z-0747-2016 ยท HTC Pliers, Surgical
The Anspach Effort, Inc.
Synthes Small Electric Drive (SED). For use in general traumatology.
| Date | Feb 3, 2016 (initiated Aug 14, 2014) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| 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 |
| Quantity | 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, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.