Z-2389-2015Class II

Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total...

Name: Z-2389-2015 Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-05-29
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-05-29 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial... on 2015-05-29. FDA classified it as Class II and gives the reason as "Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209)". 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-2389-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Posted: 2015-08-14
Terminated: 2016-09-26
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Stryker Orthopaedics sent a recall notification via email on 5/29/2015 to their local branches. Notification letters and Product Accountability Forms were sent to Stryker branches/agencies with return receipts on 7/2/2015.
Quantity in commerce: 10 units
Distribution: OH, SC, RI, WV
Product codes and lots: Catalog number 5530-G-209 Lot Code LEF064

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2389-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2389-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14

Product code MBH

K141056Class IITriathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics / cleared 2014-08-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)