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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Mitek

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  Class 2 Device Recall Depuy Mitek see related information
Date Initiated by Firm June 27, 2011
Date Posted August 31, 2011
Recall Status1 Terminated 3 on January 19, 2012
Recall Number Z-3106-2011
Recall Event ID 59229
Product Classification manual orthopedic 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/
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact james Kenney
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.