FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades recallZ-0658-2016 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Nov 20, 2015
Class II Terminated All recalls posted in January 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0658-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 20, 2015
- Posted by the FDA
- Jan 15, 2016
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- 115 units
- Product code
- HRX
- FDA submissions
- K954465
- Distribution
- Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
Product 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.
Code information (models, lots, serial numbers)
Lot Number: M1505056
Other devices under the same FDA submission
8 devices cleared under K954465 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
- FMS 283812Medos International Sàrl · Arthroscope374 reports
- FMS 283573Medos International Sàrl · ARTHROSCOPE133 reports
- FMS 283712Medos International Sàrl · Arthroscope39 reports
- FMS 284176Depuy Mitek, LLC · ARTHROSCOPE33 reports
- FMS 284172Depuy Mitek, LLC · ARTHROSCOPE4 reports
- FMS 281113Medos International Sàrl · ARTHROSCOPE3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 72697).
- Z-0656-2016 · TerminatedFMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
- Z-0657-2016 · TerminatedFMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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