Recall Z-0931-2015 ยท HTC Pliers, Surgical
Synthes (USA) Products LLC
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue.
| Date | Jan 7, 2015 (initiated Nov 6, 2014) |
| Status | Terminated |
| Reason | The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infection are also potential risks. |
| Root cause | Device Design |
| Action | DePuy Synthes sent an Urgent Notice: Medical Device Removal letter dated November 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify their consignees using the hospital personnel letter, dated November 6, 2014, as their template for their consignee notification letter, review their inventory and remove the affected lots from stock. Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 4 of this letter) by checki |
| Quantity | 12 |
| Distribution | US Nationwide Distribution to Florida only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.