Recall Z-1017-2016 ยท HTC Pliers, Surgical
The Anspach Effort, Inc.
Synthes Small Electric Drive (SED)
| Date | Feb 25, 2016 (initiated Nov 14, 2014) |
| Status | Open, Classified |
| Reason | May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start. |
| Root cause | Other |
| Action | On November 13, 2014 DePuySynthes sent a letter to all their consignees informing them of the recall and asked them to return the product. A letter and a response letter were sent to all customers that received the device. For contact - The Complaint Handling Unit Manager at 561-494-3673 or the customer DePuy Synthes Sales Consultant. |
| Quantity | 302 (23 in the USA and 279 OUS) |
| Distribution | CO, FL, LA, ID, CA, KS, IL, TX, VA, MI, NC, WA, AR, NY, NC, AZ, and Hawaii Canada, Hong Kong, Chile, Israel, Poland, Turkey, Itly, Malaysia, Ireland, Korea, Germany, Spain, Norway, Sweeden, England, Fiji, Switzerland, Belgium, Austria, Netherlands, France, Japan, China, India, Thailand, Russia, Za |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.