Reported Dec 30, 2015 · Terminated
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The…
Arthrosurface, 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: Arthrosurface, Inc. · 28 Forge Pkwy · Franklin, MA · 02038
Is this the product you have?
- Total Toe Instrument Kit
- Labeled in part"Instrument Set, 15mm Toe, Dorsal Flange Combi"
- Part Number9000-3002 The component in question is the hex driver (part number 2009-4001)
- Lot codes and dates
- SN 000242 SN 000244 SN 000246 SN 000247
- Amount recalled
- 3 units
Where it was sold
Why it was recalled
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
This product could cause temporary or reversible health problems — stop using it.
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