Recall Z-1553-2015 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
The Anspach Effort, Inc.
Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
| Date | Apr 30, 2015 (initiated Mar 24, 2015) |
| Status | Terminated |
| Reason | The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user. |
| Root cause | Device Design |
| Action | DePuySynthes sent a "URGENT NOTICE: MEDICAL DEVICE RECALL- CORRECTION" letter dated March 24, 2015 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers review the inventory and perform the in-process inspection outlined in the letter attachment, a review and repair will be implemented if necessary during the next visit schedule maintenance interval at the customer site. Customers having questions regarding this notice should contact the firm Complaint Handling Unit Manager at 561-494-3673 or to cont |
| Quantity | 12,085 pieces |
| Distribution | Worldwide Distribution - US (nationwide including DC, Hawaii, and Puerto Rico) and Internationally to Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Brazil, Canada, China, Chile, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Great Britain, Greece, G |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.