FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Recall
- Recall Number
- Z-0658-2016
- Event Number
- 72697
- Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- FEI Number
- 1221934
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 20, 2015
- Posted
- January 15, 2016
- Terminated
- April 12, 2017
- Address
- 325 Paramount Drive, Raynham, MA, 02767-5199
Description
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
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 ([email protected]) 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.
Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
115 units