FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
- Recall number
- Z-1553-2015
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
- Status
- Terminated
- Initiated
- 2015-03-24
- Posted
- 2015-04-30
- Terminated
- 2016-12-14
- 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 contact their Depuy Synthes Sales Consultant. For questions regarding this recall call 561-627-1080.
- 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, 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.
- Lot, serial or model codes
- ALL Lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWE
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28