Date Initiated by Firm | April 01, 2013 |
Date Posted | May 02, 2013 |
Recall Status1 |
Terminated 3 on July 01, 2013 |
Recall Number | Z-1213-2013 |
Recall Event ID |
64859 |
510(K)Number | K091956 |
Product Classification |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer - Product Code OIY
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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 TX 78758
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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 | 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 |
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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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510(K) Database | 510(K)s with Product Code = OIY
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