Z-1917-2009

Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704...

Name: Z-1917-2009 Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-02-12
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-02-12 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704, 6541-5-705, 6541-5-706, 6541-5-707, & 6541-5-708... on 2007-02-12. The reason FDA records is "Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle". 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-1917-2009
Status: Terminated
Initiated: 2007-02-12
Posted: 2009-08-26
Terminated: 2009-10-15
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704, 6541-5-705, 6541-5-706, 6541-5-707, & 6541-5-708; Triathlon MIS Instruments; Non Sterile: Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Important Product Correction letters were sent to all branches/agencies on February 12, 2008 by Federal Express. The letter asked consignees to examine their inventory and hospital locations to identify the affected product. Customers were asked to perform a functional inspection by assembling the Triathlon Impactor/Extractor Handle to all of their MIS Cutting Blocks. If the cutting block does not assemble, customers are to list the affected lot codes on the Attached Product Accountability Form and fax a copy to (201) 831-6069. The letter states that product should not be returned until further instructions are received. Questions should be directed to (201) 831-5825.
Quantity in commerce: 690 - both varieties
Distribution: Worldwide Distribution
Product codes and lots: Catalog numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704, 6541-5-705, 6541-5-7-6, 6541-5-707, 6541-5-708. All lot codes.

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)