FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
FDA Recall Z-0658-2016 · Posted 2016-01-15
Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
Recall StatusTerminated
Product CodeHRX
Date Initiated2015-11-20
Date Terminated2017-04-12
Product Quantity115 units
Reason for Recall
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.