FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
This recall has been terminated (originally issued January 15, 2016).
- Recall Initiated
- November 20, 2015
- Posted
- January 15, 2016
- Terminated
- April 12, 2017
- Recall Number
- Z-0656-2016
- Quantity
- 50 units
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Distribution
Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
Lot / Code Info
Lot Number: M1505055
Root Cause
Process control
Action Taken
On November 20, 2015, customers were notified of the recall via letter. They were asked to take the following actions: Customer immediate actions: 1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located within your facility; 2. Review, complete, sign and return the attached business reply form to Elizabeth Messana (emessan1@its.jnj.com) in accordance with the directions on the business reply form within 5 business days of receipt of this notification; 3. Forward this notice to anyone in your facility that needs to be informed; 4. If any potentially affected product has been forwarded to another facility, contact Elizabeth Messana at 508-828-3150; 5. Keep a copy of this notice.