Howmedica Osteonics Corp.: Medical Device Recall in 2024 - (Recall #: Z-1265-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

Product Classification:

Class II

Date Initiated: February 6, 2024

Date Posted: March 13, 2024

Recall Number: Z-1265-2024

Event ID: 94026

Reason for Recall:

Potential packaging breaches of inner blister and outer sterile blister.

Status: Ongoing

Product Quantity: 24 units (US); 1 unit (OUS)

Code Information:

Part No. 5537-G-416-E; GTIN: 07613327287745; Lot No. H21A0K, XY776E; Expiration Date: 10/07/2028.

Distribution Pattern:

Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.

Voluntary or Mandated:

Voluntary: Firm initiated