Recall Z-3106-2011 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).
| Date | Aug 31, 2011 (initiated Jun 27, 2011) |
| Status | Terminated |
| Reason | Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head. |
| Root cause | Process change control |
| Action | Depuy Mitek issued Original Customer Notification Letter on 6/27/11 and an Updated letter to clarify the lot number information sent 6/29/11. Hospitals requested to immediately check all inventories for affected product and return for repalcement product. Also notify surgeons aware of this potential issue and potential risk of a delay in surgery. questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3. |
| Quantity | 75 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.