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Terminated

Apex Pilot Shaft 13mm

FDA Recall Z-0715-04 · Posted 2004-07-20

Recalling FirmApex Surgical, LLC
Recall StatusTerminated
Product CodeHTO
Date Initiated2003-01-17
Date Terminated2004-04-01
Product Quantity45 units

Reason for Recall

Pilot shaft may break during reaming or broaching of the femur

Firm Action

Apex Surgical notified accounts by letter on 1/17/03, advising users to discontinue use of the stem pilots and return the pilots, and associated broaches and reamers because they would not be interchangeable with the new design.

Root Cause

Other

Distribution Pattern

CT, OH, FL, OK, TX, RI, NV, SC,

Official Source

View FDA Recall →

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

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