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Terminated

TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

FDA Recall Z-0013-06 · Posted 2005-10-07

Recalling FirmPlus Orthopedics USA
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-08-03
Date Terminated2006-06-16
Product Quantity15

Reason for Recall

Did not meet specifications.

Firm Action

Recall was by scripted telephone conversations to two consignees. Products were returned under RMA.

Root Cause

Other

Distribution Pattern

Arizona, California, Idaho, New York, Texas, and Virginia

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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