Recall Z-0676-2012 ยท HTW Bit, Drill
Synthes USA (HQ), Inc.
Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical instrument is a non powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
| Date | Jan 11, 2012 (initiated Nov 2, 2011) |
| Status | Terminated |
| Reason | Synthes is initiating a recall of the Drill Bit for 5.0mm Recon Screws with large Quick Coupling due to the potential for the drill stop to slip on the drill bit. |
| Root cause | Component design/selection |
| Action | On November 2, 2011 the firm sent "Notice: Medical Device Recall" letters to all consignees, with return receipt request. The letter requested consignees cease use of the device and remove the product from inventory. For questions, call 610-719-5450 or contact your sales consultant. |
| Quantity | 577 |
| Distribution | Product was distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, ME, MD, MI, MN, MT, LA, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TX, UT, VA, WA, WV, WI, and WY. GOVERNMENT account is Audie Murphy VA Hospital, Chief Supply Svc Whse #1, 7400 Merton Minter |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.