Z-2302-2012Class II

3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert...

Name: Z-2302-2012 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert...
Creator: Encore Medical, Lp
Published: 2012-08-09
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2012-08-09 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of 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... on 2012-08-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2302-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Posted: 2012-08-30
Terminated: 2013-01-25
Recalling firm: Encore Medical, LP
Product: 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.
Product code: OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: 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.
Quantity in commerce: 7 units
Distribution: Worldwide Distribution including Venezuela.
Product codes and lots: Model Number 392-09-706, Lot Number 59602519

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2302-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2302-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-30

Product code OIY

K091956Class IIHighly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P. / cleared 2010-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)