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U.S. Department of Health and Human Services

Class 2 Device Recall Exprt Precision System: Revision Knee

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 Class 2 Device Recall Exprt Precision System: Revision Kneesee related information
Date Initiated by FirmSeptember 16, 2015
Date PostedOctober 26, 2015
Recall Status1 Terminated 3 on January 04, 2016
Recall NumberZ-0165-2016
Recall Event ID 72216
510(K)NumberK140830 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer - Product Code OIY
ProductExprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
Code Information 471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information ContactDesiree Wells
512-832-6302
Manufacturer Reason
for Recall		The labeling is missing the size/diameter information.
FDA Determined
Cause 2		Labeling design
ActionDJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.
Quantity in Commerce209 units
DistributionUS Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = OIY
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