Recall Z-2345-2015 ยท HTZ Instrument, Cutting, Orthopedic
The Anspach Effort, Inc.
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
| Date | Aug 5, 2015 (initiated Jul 1, 2015) |
| Status | Terminated |
| Reason | Saw head separated from the drive unit or began to come loose. |
| Root cause | Nonconforming Material/Component |
| Action | DePuy Synthes sent an " Urgent Notice Medical Device Recall (Removal) letter dated July 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTION REQUIRED: Our records show that your facility has the affected product(s) subject to this removal. The Anspach Effort, on behalf of DePuy Synthes asks that you review your inventory and immediately remove any affected BPLII Battery Oscillator devices from stock. In addition to this letter, your DePuy Synthes Sales Consultant has been provided with new product(s) to imm |
| Quantity | 360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked) |
| Distribution | Worldwide Distribution - US Distribution to the states of : AR, LA, OH, and WA., and the countries of : China, France, Italy, Russia, South Africa, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.