Reported Jul 9, 2014 · Terminated
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
The Anspach Effort, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Anspach Effort, Inc. · 4500 Riverside Drive · Palm Beach Gardens, FL · 33410-4235
Is this the product you have?
- Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
- Lot codes and dates
- DFU18-0047:
- Revisions A & B 18-0074Revision A
- and 18-0105Revisions A
- Operating Manuals19-0010: Revisions A
- and 19-0013Revisions A, B, & C
- Amount recalled
- 115,988 units
Where it was sold
Why it was recalled
Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.
This product could cause temporary or reversible health problems — stop using it.
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