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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Total Knee CDS

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 Class 2 Recall
Medline Total Knee CDS
see related information
Date Posted December 17, 2012
Recall Status1 Terminated on December 17, 2012
Recall Number Z-0532-2013
Recall Event ID 63520
Product Classification General Surgery Tray (Kit) - Product Code LRO
Product Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
Code Information Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013
Recalling Firm/
Manufacturer
Medline Industries Inc
1 Medline Pl
Mundelein, Illinois 60060
Manufacturer Reason
for Recall
The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Medline Industries Inc notified the sole direct account on September 20, 2012 via telephone that the affected custom pack were recalled. Instruction was provided to the staff at the facility not to use the pack until it had been reworked with a sterile back table cover.
Quantity in Commerce 18 packs
Distribution US (nationwide) in the state of West Virginia
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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