Apex Pilot Shaft 16mm
FDA device recall Z-0717-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Apex Surgical, LLC
- Reason for recall
- Pilot shaft may break during reaming or broaching of the femur
- Action taken
- 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
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 45 units
- Distribution
- CT, OH, FL, OK, TX, RI, NV, SC,
- Date initiated
- 2003-01-17
- Date posted
- 2004-07-20
- Date terminated
- 2004-04-01
- Location
- Lakeville, MA
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