Z-1265-2024Class II

No 4 Triathlon Ts Plus Tib Ins X3 Poly 16 Mm

Name: Z-1265-2024 No 4 Triathlon Ts Plus Tib Ins X3 Poly 16 Mm
Creator: Howmedica Osteonics Corp.
Published: 2024-02-06
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2024-02-06 / Open, Classified / root cause: packaging

FDA source

Howmedica Osteonics Corp. began a recall of NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM on 2024-02-06. FDA classified it as Class II and gives the reason as "Potential packaging breaches of inner blister and outer sterile blister". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1265-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-06
Posted: 2024-03-06
Recalling firm: Howmedica Osteonics Corp
Product: No 4 Triathlon Ts Plus Tib Ins X3 Poly 16 Mm
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Potential packaging breaches of inner blister and outer sterile blister.
Root cause tag: packaging
FDA root cause: Packaging
Action: URGENT MEDICAL DEVICE RECALL notifications dated 02/06/2024 were distributed to consignees by mail. Consignees were asked to forward the provided recall notice to all individuals within the organization who need to be made aware and organizations who have consigned product, immediately check all stock and operating room storage for affected devices, quarantine and discontinue use of recalled devices, complete and return the provided Business Reply Form by email to [email protected] or by fax to 855-800-1093. Consignees are to contact their local sales office or Stryker Sales Representative for product replacement and inventory questions. Recalled devices are to be returned to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team, 325 Corporate Drive, Dock M-East, Mahwah, NJ 07430; include "Ref PFA 3524019" on shipment. Consignees with any questions are to call the firm at 201-831-5000 or by email at [email protected]. An URGENT MEDICAL DEVICE RECALL UPDATE, dated 3/18/24, was sent to consignees.
Quantity in commerce: 24 units (US); 1 unit (OUS)
Distribution: Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Product codes and lots: Part No. 5537-G-416-E; GTIN: 07613327287745; Lot No. H21A0K, XY776E; Expiration Date: 10/07/2028.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1265-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1259-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-06
Z-1260-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-06
Z-1261-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-06
Z-1262-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-06
Z-1263-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-06
Z-1264-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-06
Z-1265-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-06
Z-1266-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-06

Product code MBH

K172634Class IITriathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics / cleared 2017-11-16

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)