Z-0910-2010

Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ...

Name: Z-0910-2010 Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-02-17
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-02-17 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with femoral components in... on 2006-02-17. The reason FDA records is "Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts". 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-0910-2010
Status: Terminated
Initiated: 2006-02-17
Posted: 2010-03-02
Terminated: 2010-03-03
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with femoral components in primary or revision total knee arthroplasty.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm. For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.
Quantity in commerce: 594 units total - all products.
Distribution: Worldwide Distribution -- United States and Canada.
Product codes and lots: Lot Numbers: 36325001; 36325102;36325302; 36325402; 36325602; 36326002; 36326201;33936308; 36605501; 36326601; 33934303; 33934705; 36327201; 36327301; 36327401; 36328101; 35453302; 36378501; 36604001; 36379001; 36379101; 36379201; 36379301; 36379401; 36604301; 36379501; 36604502; 36379901; 36326301; 36380001; 36380101; 35728201; 36380401; 36380601; 36380901; 36381201; 36381401; 35730101; 36381601; 35730602; 35921201; 35921301; 36382001; 35730801; 35730802; 35730803 and 36382101.

Product code JWH

K031729Class IITriathlon Posteriorly Stabilized (Ps) Total Knee SystemHowmedica Osteonics Corp. / cleared 2003-09-02

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)