FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Reported: January 27, 2016 Initiated: November 20, 2015 #Z-0657-2016
Product Description
FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Reason for Recall
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Details
- Recalling Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Units Affected
- 45 units
- Distribution
- Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.. Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co.. Units affected: 45 units.
Why was this product recalled? ▼
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2016. Severity: Moderate. Recall number: Z-0657-2016.
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