Z-1653-2023Class II

TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E

Name: Z-1653-2023 TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Creator: Howmedica Osteonics Corp.
Published: 2023-04-13
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2023-04-13 / Open, Classified / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E on 2023-04-13. FDA classified it as Class II and gives the reason as "Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1653-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-13
Posted: 2023-05-30
Recalling firm: Howmedica Osteonics Corp
Product: TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Stryker issued Urgent Medical Device Recall letter n 4/13/23 via UPS 2-Day Air Product Field Action #: 3268231. Letter states reason for recall and action to take: Our records indicate that you may have received the affected product(s). It is Stryker's responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to [email protected] / Fax: (877) 546-0444. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices back to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3268231 Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. Contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email [email protected]
Quantity in commerce: 24 units in total
Distribution: US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan
Product codes and lots: GTIN: 07613327390698 Lot Number: JH3AHJ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1653-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1653-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30
Z-1654-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30

Product code MBH

K173849Class IITriathlon Total Knee SystemStryker Orthopaedics / cleared 2018-02-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)