Z-0716-04

Apex Pilot Shaft 14.4mm

Name: Z-0716-04 Apex Pilot Shaft 14.4mm
Creator: Apex Surgical, LLC
Published: 2003-01-17
License: https://open.fda.gov/license/

VQ Orthocare / initiated 2003-01-17 / Terminated

FDA source

Apex Surgical, LLC began a recall of Apex Pilot Shaft 14.4mm on 2003-01-17. The reason FDA records is "Pilot shaft may break during reaming or broaching of the femur". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0716-04
Status: Terminated
Initiated: 2003-01-17
Posted: 2004-07-20
Terminated: 2004-04-01
Recalling firm: VQ Orthocare
Product: Apex Pilot Shaft 14.4mm
Product code: HTO Reamer
Reason for recall: Pilot shaft may break during reaming or broaching of the femur
FDA 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 in commerce: 45 units
Distribution: CT, OH, FL, OK, TX, RI, NV, SC,
Product codes and lots: Catalog Number: 690114 Lot NUmbers: 052, 113, 214

Product code HTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)