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Terminated

TC-PLUS Solution Tibial Component-- Symmetric

FDA Recall Z-0017-04 · Posted 2003-10-15

Recalling FirmPlus Endoprothetik AG
Recall StatusTerminated
Date Initiated2003-04-17
Date Terminated2003-12-03
Product Quantity15

Reason for Recall

Labeling/packaging mix-up.

Firm Action

Firm notified implanting surgeons by letter and telephone on May 16, 2003 and on June 2, 2003. One physician was contacted on August 26, 2003. The firm communicated the need to follow-up with the patients . Recall is complete.

Root Cause

Other

Distribution Pattern

TX, CA, VA, ID, NY, UT, FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000666TC-PLUS SOLUTION KNEEPlus Orthopedics · 2000-10-13

Official Source

View FDA Recall →

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

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