Reported Jan 27, 2016 · Terminated
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving,…
DePuy Mitek, Inc., a Johnson & Johnson Co.
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: DePuy Mitek, Inc., a Johnson & Johnson Co. · 325 Paramount Drive · Raynham, MA · 02767-5199
Is this the product you have?
- FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades
- Product Code287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures
- Lot codes and dates
- Lot NumberM1505056
- Amount recalled
- 115 units
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
Why it was recalled
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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