Reported Nov 20, 2013 · Terminated
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax…
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?
- Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with
- the Pneumatic Motor Systems includingBlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers
- Product UsageIndication for use is cutting and shaping bone
- Lot codes and dates
- part numbers 19-0005
- Amount recalled
- 2,020
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th
This product could cause temporary or reversible health problems — stop using it.
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