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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Mitek

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 Class 2 Recall
Depuy Mitek
see related information
Date Posted August 31, 2011
Recall Status1 Terminated on January 19, 2012
Recall Number Z-3106-2011
Recall Event ID 59229
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).
Code Information Finished Goods (Box label) Lot Numbers: 1105101 and 1106132. Component lot number Etched on Reusable Handle 1012001 and 1106001
Recalling Firm/
Manufacturer
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham, Massachusetts 02767
For Additional Information Contact james Kenney
508-880-8100
Manufacturer Reason
for Recall
Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 75 units
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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