FDA Medical Device Recalls (openFDA)
DePuy Mitek, Inc., a Johnson & Johnson Co.: 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 number
- Z-0658-2016
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Product
- FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
- Status
- Terminated
- Initiated
- 2015-11-20
- Posted
- 2016-01-15
- Terminated
- 2017-04-12
- Reason
- Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- Root cause
- Process control
- 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 (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.
- Quantity
- 115 units
- Distribution
- Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
- Lot, serial or model codes
- Lot Number: M1505056
- 510(k) numbers
- ["K954465"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 1221934
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28