Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
Reported: May 6, 2015 Initiated: March 24, 2015 #Z-1553-2015
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.
Details
- Recalling Firm
- The Anspach Effort, Inc.
- Units Affected
- 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, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Lebanon, Sri Lanka, Libyan Arab Jamahiriya, Morocco, Macedonia, Mexico, Malaysia, Netherlands, Norway, Nepal, New Zealand, Oman, Ontario, Peru, Philippines, Palestine, Portugal, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, South Africa, El Salvador, Thailand, Turkey, Taiwan, Ukraine, Uruguay, Venezuela, Vietnam and United Arab Emirates.
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.. Recalled by The Anspach Effort, Inc.. Units affected: 12,085 pieces.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2015. Severity: Moderate. Recall number: Z-1553-2015.
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