Z-1213-2013Class II

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

Name: Z-1213-2013 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System
Creator: Encore Medical, Lp
Published: 2013-04-01
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2013-04-01 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System on 2013-04-01. FDA classified it as Class II and gives the reason as "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...". 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-1213-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-01
Posted: 2013-05-02
Terminated: 2013-07-01
Recalling firm: Encore Medical, LP
Product: 3DKnee e+ Tibial Insert. The insert is 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: 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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1213-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1213-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-05-02

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)