Z-0399-2007

Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica...

Name: Z-0399-2007 Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-12-04
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-12-04 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp on 2006-12-04. The reason FDA records is "A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0399-2007
Status: Terminated
Initiated: 2006-12-04
Posted: 2007-02-08
Terminated: 2007-02-21
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.
Quantity in commerce: 23 units
Distribution: Nationwide and Canada.
Product codes and lots: Ref. No. 5530-G-211 Lot code G9XF6 LAF974

Product code JWH

K051146Class IITriathlon Knee SystemHowmedica Osteonics Corp. / cleared 2005-07-13

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)