Z-0964-2013Class II

Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment...

Name: Z-0964-2013 Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-01-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-01-24 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis... on 2013-01-24. FDA classified it as Class II and gives the reason as "The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed". 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-0964-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-24
Posted: 2013-03-18
Terminated: 2015-05-06
Recalling firm: Howmedica Osteonics Corp
Product: Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: A Notification Letter/Product Accountability Form dated 01/28/2013 was sent via FedEx on 01/28/2013 to the sole US branch receiving the affected devices. The branch was instructed to also contact the hospitals in its territory that have the affected product to arrange return of the product. Affected products to be returned to Stryker Orthopaedics, 325 Corporate Drive, Mahway, NJ 07430.
Quantity in commerce: 4 units (total of 2 sets)
Distribution: 1 Branch (NJ) with one consignee (DE).
Product codes and lots: Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right). Lot Codes: AP5W52 and AP7H19.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0964-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0964-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18

Product code LXH

K053514Class IITriathlon Total Knee SystemStryker Orthopaedics / cleared 2006-01-26

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)