Z-0659-03

TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016

Name: Z-0659-03 TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016
Creator: Interpore Cross International Inc
Published: 2003-02-07
License: https://open.fda.gov/license/

Interpore Cross International Inc / initiated 2003-02-07 / Terminated

FDA source

Interpore Cross International Inc began a recall of TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016 on 2003-02-07. The reason FDA records is "Instrument fell apart during cleaning prior to surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0659-03
Status: Terminated
Initiated: 2003-02-07
Posted: 2003-03-20
Terminated: 2003-08-28
Recalling firm: Interpore Cross International Inc
Product: TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Instrument fell apart during cleaning prior to surgery.
FDA root cause: Other
Action: Firm telephoned customers on 2/7/2003 requesting that they immediately return thier instruments.
Quantity in commerce: 37 units
Distribution: States of NJ, CA, PA, MN, WI, MO, FL, OH, VA, MD, Wash DC, NY, CO, MA and to Brazil, Mexico, England, Denmark, Belgium, Australia.
Product codes and lots: Lot 32688

Product code LXH

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)