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Terminated

Finger Joint Implants, Silicone Models TRL-10 and TRL-20

FDA Recall Z-0710-03 · Posted 2003-04-09

Recalling FirmAvanta Orthopaedics, Inc.
Recall StatusTerminated
Product CodeKYI
Date Initiated2003-01-24
Date Terminated2004-12-01
Product Quantity43

Reason for Recall

Wrong silicone elastomer used in construction.

Firm Action

Recall was initiated by telephone on 1/24/2003. All customers responded by 1/28/2003. All units have been accounted for. The units have been returned. The recall is complete.

Root Cause

Other

Distribution Pattern

States of CA and UT and to France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964381AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANTAvanta Orthopaedics, Inc. · 1997-01-22

Official Source

View FDA Recall →

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

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