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Terminated

Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02

FDA Recall Z-0196-2007 · Posted 2006-11-21

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-08-31
Date Terminated2012-05-03
Product Quantity30

Reason for Recall

Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.

Firm Action

The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine.

Root Cause

Other

Distribution Pattern

International distribution only---- including countries of South America, Africa and Europe

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010434OPTETRAK B-SERIES TOTAL KNEE SYSTEMExactech, Inc. · 2001-03-13

Official Source

View FDA Recall →

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

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