Z-2157-2008

Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog numbers: 5565-T-009...

Name: Z-2157-2008 Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog numbers: 5565-T-009...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-05-14
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-05-14 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog numbers: 5565-T-009, 5565-T-010, 5565-T-011, 5565-T-012, 5565-T-013, 5565-T-014... on 2008-05-14. The reason FDA records is "Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2157-2008
Status: Terminated
Initiated: 2008-05-14
Posted: 2008-08-23
Terminated: 2010-01-26
Recalling firm: Howmedica Osteonics Corp
Product: Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog numbers: 5565-T-009, 5565-T-010, 5565-T-011, 5565-T-012, 5565-T-013, 5565-T-014 5565-T-015, 5565-T-016, 5565-T-017, 5565-T-018, 5565-T-019, 5565-T-020 5565-T-021, 5565-T-022, 5565-T-023, 5565-T-024, 5565-T-025 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Used in Revision TKA.
Product code: HWT Template
Reason for recall: Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Product Recall notification letters were sent to all Stryker Branch/Agency Manager/Quality contacts on May 14, 2008 via Federal Express. The letter requests that consignees examine their inventory and hospital consignment locations to identify the product; and retrieve all affected product lots and return it to their branch or agency warehouse for reconciliation. The letter also states that a Stryker Orthopaedics Customer Service rep should be contacted for alternative products available.
Quantity in commerce: Catalog Number 5565 T-009 to 025: 2629 US, 238 international: Catalog 5566 T-009 to 025: 2625 US, 239 international
Distribution: Worldwide Distribution --- including USA and countries of Australia, Canada, Sweden, Germany, Spain, Portugal, United Kingdom.
Product codes and lots: All lot codes

Product code HWT

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)