Class II — The Anspach Effort, Inc.
| Recalling firm | THE ANSPACH EFFORT, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| Product | Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery. |
| 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,… |
| Initiated | 2015-03-24 |
| Classified | 2015-04-30 |
| Terminated | 2016-12-14 |
| Recall number | Z-1553-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — The Anspach Effort, Inc. (Z-1553-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70919/
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