CLASS II Device recall · Reported 27 Jan 2016 · FDA Enforcement Report
FMS Ultra-Aggressive Cutter Shaver Blades recalled
DePuy Mitek, Inc., a Johnson & Johnson is recalling FMS Ultra-Aggressive Cutter Shaver Blades, distributed in Delaware, Maine, Michigan, Ohio, Texas. The recall was initiated on 20 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0658-2016
- FDA event ID
- 72697
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2015
- FDA classified
- 15 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 20 Nov 2015 | Recall initiated by company | |
| 15 Jan 2016 | Classified by FDA | +56 days |
| 27 Jan 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Product as listed by the FDA
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Where it was distributed
Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
Questions about this recall
Why was it recalled?
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Which lots are affected?
Lot Number: M1505056
Where was it sold?
Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 72697This product is part of a recall event; the main page for the event is FMS neXtra¿ Aggressive Cutter Shaver Blades recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | FMS neXtra¿ Aggressive Cutter Shaver Blades recalled | DePuy Mitek, Inc., a Johnson & Johnson | Labeling Errors | 5 states | |
| CLASS II | FMS neXtra¿ Full Radius Cutter Shaver Blades recalled | DePuy Mitek, Inc., a Johnson & Johnson | Labeling Errors | 5 states |
More recalls from DePuy Mitek, Inc., a Johnson & Johnson
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | COR Disposable Kit w/ Perpendicularity recalled | DePuy Mitek, Inc., a Johnson & Johnson | Other | Nationwide |
| Device | CLASS II | COR Disposable Kit Cartilage Transplant System recalled | DePuy Mitek, Inc., a Johnson & Johnson | Other | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Rapid w/ Pan-Indicated for use recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Plus w/ Ethibond-Iindicated recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Rapid W/ OC-Indicated for use recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |