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U.S. Department of Health and Human Services

Class 2 Device Recall CLP Instrumentation Removal Hook

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  Class 2 Device Recall CLP Instrumentation Removal Hook see related information
Date Initiated by Firm November 10, 2010
Date Posted December 28, 2010
Recall Status1 Terminated 3 on April 25, 2011
Recall Number Z-0828-2011
Recall Event ID 57286
Product Classification Extractor - Product Code HWB
Product CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
Code Information Device Listing Number: A776463. Device Part Number: 803-08-033. Lot/Serial Numbers: 34596L02, 32503L02, 32503L01(B)
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		 Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.
FDA Determined
Cause 2		 Other
Action DJO issued an Urgent Recall Notice letter dated November 10, 2010 to consignees identifying the affected devices and requesting return of all affected devices for replacement. Customers are also requested to complete and return an enclosed Recall Response Form. Customers can contact David Harris of DJO at 512 834-6330 with questions about this recall.
Quantity in Commerce 27 Units
Distribution Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI.
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.
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