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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 Recall
CLP Instrumentation Removal Hook
see related information
Date Posted December 28, 2010
Recall Status1 Terminated 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, Texas 78758
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/UNDETERMINED: Pending
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 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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