FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades recall
FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue…
Why was FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades recalled?
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: M1505055
- Product
- FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue…
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- 50 units
- Distribution
- Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
- Recall date
- January 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)