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3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material:… recallZ-2302-2012 · Encore Medical, Lp · initiated Aug 9, 2012

Class II Terminated All recalls posted in August 2012

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

The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.

FDA root cause category: Incorrect or no expiration date

What the company is doing

DJO Global sent an Urgent Field Safety Notice dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Notice to all those who need to be aware within their organization or to any organization where the potentially affected product has been transferred. Customers were instructed to contact the firm to place a replacement order and receive an RMA number. For questions customers were asked to call 512-834-6255. For questions regarding this recall call 512-832-9500.

Recall details

Recall number
Z-2302-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 9, 2012
Posted by the FDA
Aug 30, 2012
Recalling firm
Encore Medical, Lp
Quantity
7 units
Product code
OIY
FDA submissions
K091956
Distribution
Worldwide Distribution including Venezuela.

Product description

3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.

Code information (models, lots, serial numbers)

Model Number 392-09-706, Lot Number 59602519

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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