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U.S. Department of Health and Human Services

Class 2 Device Recall Tibial Insert

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 Class 2 Recall
Tibial Insert
see related information
Date Posted May 02, 2013
Recall Status1 Terminated on July 01, 2013
Recall Number Z-1213-2013
Recall Event ID 64859
Premarket Notification
510(K) Number
K091956 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive - Product Code OIY
Product 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Code Information Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
Recalling Firm/
Manufacturer
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
For Additional Information Contact Teffany Hutto
512-832-9500
Manufacturer Reason
for Recall
U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action The firm sent their US customer a "Urgent Field Safety Notice" letter on April 1, 2013. The letter explained the product problem and provided recommended actions as well as customer contact numbers.
Quantity in Commerce 5
Distribution US Distribution to the state of California and International Distribution to the country of Venezuela.
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.
510(K) Database 510(K)s with Product Code = OIY and Original Applicant = ENCORE MEDICAL, L.P.
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