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Terminated

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

FDA Recall Z-1213-2013 · Posted 2013-05-02

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeOIY
Date Initiated2013-04-01
Date Terminated2013-07-01
Product Quantity5

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

US Distribution to the state of California and International Distribution to the country of Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091956HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712Encore Medical L.P. · 2010-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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