Recall Z-1553-2015— The Anspach Effort, Inc.
Class II · Terminated
Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2015-03-24, terminated 2016-12-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.. 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..
- Recalling firm
- The Anspach Effort, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-24
- Terminated
- 2016-12-14
- Firm location
- Palm Beach Gardens, FL, United States
Product description
Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.