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Terminated

3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.

FDA Recall Z-1433-2010 · Posted 2010-04-26

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2010-03-19
Date Terminated2010-07-22
Product Quantity7 units

Reason for Recall

Affected product had incorrect color label which is a secondary visual indicator for sizing.

Firm Action

Encore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm. For further information, contact Encore Medical, LP at 1-888-838-3668.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution -- United States (UT, IA) and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0201143D KNEEEncore Orthopedics, Inc. · 2002-07-12

Official Source

View FDA Recall →

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

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