Z-1462-2018Class II

Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile...

Name: Z-1462-2018 Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile...
Creator: Howmedica Osteonics Corp.
Published: 2018-01-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2018-01-30 / Terminated / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total... on 2018-01-30. FDA classified it as Class II and gives the reason as "Customers may receive the incorrect size implant from what is labeled on the box". 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-1462-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-30
Posted: 2018-04-20
Terminated: 2020-05-07
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Customers may receive the incorrect size implant from what is labeled on the box.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On January 31, 2018 branches/agencies received notification of the recall via e-mail and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to branches, agencies & hospital risk management via UPS (with return receipt) on January 31, 2018 with an expected arrival date of February 02, 2018. Customers were asked to complete a Notification Business Reply Form and return via e-mail or fax. Affected product is to be returned to the manufacturer. Customers with questions may contact (201)831-6693.
Quantity in commerce: 77 total products
Distribution: USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA
Product codes and lots: Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1462-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1462-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20

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)