FDA Medical Device Recalls (openFDA)
Apex Surgical, LLC: Apex Pilot Shaft 13mm
- Recall number
- Z-0715-04
- Recalling firm
- Apex Surgical, LLC
- Product
- Apex Pilot Shaft 13mm
- Status
- Terminated
- Initiated
- 2003-01-17
- Posted
- 2004-07-20
- Terminated
- 2004-04-01
- Reason
- Pilot shaft may break during reaming or broaching of the femur
- Root cause
- Other
- 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.
- Quantity
- 45 units
- Distribution
- CT, OH, FL, OK, TX, RI, NV, SC,
- Lot, serial or model codes
- Catalog Number: 690113 Lot NUmbers: 052, 113, 214
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTO
- Firm FEI
- 3002757749
- Firm city
- Lakeville
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28