FDA Device

Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).

Hazard

Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head.

What You Should Do

Remedy

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.

Products

Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).
Brand
DePuy Mitek, Inc., a Johnson & Johnson Co.
UPC
Finished Goods (Box label) Lot Numbers: 1105101 and 1106132. Component lot number Etched on Reusable Handle 1012001 and 1106001

Units Affected

75 units