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Terminated

Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas

FDA Recall Z-1025-04 · Posted 2004-07-20

Recalling FirmAscension Orthopedics, Inc
Recall StatusTerminated
Product CodeNEG
Date Initiated2003-10-02
Date Terminated2004-06-17
Product Quantity107 trays

Reason for Recall

Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.

Firm Action

Recall was initiated via letter included with replacement trays begining in October 2003.

Root Cause

Other

Distribution Pattern

Nationwide distrbution to IA, TX, OH, FL, IN, MN, CO, WA, CA, MO, and to a consignee in Ontario, Canada

Official Source

View FDA Recall →

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

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