FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving,
FDA device recall Z-0657-2016 · posted 2016-01-15 · Terminated
Recall details
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Reason for recall
- Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 45 units
- Distribution
- Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
- Date initiated
- 2015-11-20
- Date posted
- 2016-01-15
- Date terminated
- 2017-04-12
- Location
- Raynham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM (K041824) | Future Medical Systems, SA | 2005-01-07 |