Z-0901-03

Trident Insert Impactor

Name: Z-0901-03 Trident Insert Impactor
Creator: Stryker Howmedica Osteonics
Published: 2003-04-28
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2003-04-28 / Terminated

FDA source

Stryker Howmedica Osteonics began a recall of Trident Insert Impactor on 2003-04-28. The reason FDA records is "The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0901-03
Status: Terminated
Initiated: 2003-04-28
Posted: 2003-05-29
Terminated: 2003-11-12
Recalling firm: Howmedica Osteonics Corp
Product: Trident Insert Impactor
Product code: HWA Impactor
Reason for recall: The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble.
FDA root cause: Other
Action: Howmedica sent recall letters and acknowledgement forms via FedEx on April 29, 2003 with return receipt.
Quantity in commerce: 1758
Distribution: The product has been distributed the Howmedica branches and sales reps, hospitals, and International Howmedica distributors located in Sweden, China, France, Netherlands, Germany, Spain, Australia, Japan, New Zealand, Switzerland, Portugal, England, Chile, and Brazil.
Product codes and lots: Catalog Number: 2111-0000

Product code HWA

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)