Z-1370-2013Class II

Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics...

Name: Z-1370-2013 Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-03-25
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-03-25 / Terminated / root cause: software

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA... on 2013-03-25. FDA classified it as Class II and gives the reason as "Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1370-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-25
Posted: 2013-05-23
Terminated: 2015-05-06
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 Meyzieu, Cedex, France This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 25, 2013 and Product Accountability Forms via Fed Ex to its Consignees/ customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the attached Notification Acknowledgment Form within 5 days via fax to 855-251-3635; contact the hospitals in your territory that have the affected product to arrange return of product; and return affected product to the attention of Regulatory Compliance Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, attach flourescent orange PRODUCT REMEDIATION sticker to your return indicating the PR #RA2013-011 and mark outer box with the words "Product Recall". If you have any questions, feel free to contact Manager, Divisional Regulatory Compliance at (201) 972-2100.
Quantity in commerce: 11 units
Distribution: Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.
Product codes and lots: Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1370-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1370-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-23

Product code JWH

K070095Class IITriathlon Ts Knee SystemHowmedica Osteonics Corp. / cleared 2007-06-01

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)