RecallRadar

FDA Device recall Z-1261-2024

X3 TRIATHLON CS INSERT NO 6 11 MM

On 2024-03-13 the FDA classified a Class II recall of X3 TRIATHLON CS INSERT NO 6 11 MM by Howmedica Osteonics, citing potential packaging breaches of inner blister and outer sterile blister.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1261-2024
ClassificationClass II
Statusongoing
Initiated2024-02-06
Published2024-03-13
Last updated2026-09-13 11:57 UTC
CompanyHowmedica Osteonics
DistributionUS

Product

X3 TRIATHLON CS INSERT NO 6 11 MM

Reason

Potential packaging breaches of inner blister and outer sterile blister.

Identifiers

code_infoPart No. 5531-G-611-E; GTIN: 07613327337341; Lot No. HL7228; Expiration Date: 11/08/2028.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1261-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.