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Terminated

UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm

FDA Recall Z-0540-05 · Posted 2005-02-15

Recalling FirmPlus Orthopedics
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-01-04
Date Terminated2005-03-03
Product Quantity10, 1 is implanted.

Reason for Recall

Knee tibial insert is mislabeled completely as different device.

Firm Action

PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert.

Root Cause

Other

Distribution Pattern

California, Idaho, Illinois, Wisconsin, Oregon

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022204VKS KNEE SYSTEMPlus Orthopedics · 2002-10-18

Official Source

View FDA Recall →

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

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