Recall Z-0656-2016 ยท HRX Arthroscope
DePuy Mitek, Inc., a Johnson & Johnson Co.
FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
| Date | Jan 15, 2016 (initiated Nov 20, 2015) |
| Status | Terminated |
| 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 |
| Quantity | 50 units |
| Distribution | Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041824 | X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM Future Medical Systems, SA, Jan 7, 2005 |