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3DKnee e+ Tibial Insert. The insert is used along with the… recallZ-1213-2013 · Encore Medical, Lp · initiated Apr 1, 2013

Class II Terminated All recalls posted in May 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, Lp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-1213-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 1, 2013
Posted by the FDA
May 2, 2013
Recalling firm
Encore Medical, Lp
Quantity
5
Product code
OIY
FDA submissions
K091956
Distribution
US Distribution to the state of California and International Distribution to the country of Venezuela.

Product description

3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

Code information (models, lots, serial numbers)

Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.

Other devices under the same FDA submission

57 devices cleared under K091956 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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