RecallRadar

FDA Device recall Z-1259-2024

X3 TRIATHLON CS INSERT NO 3 10 MM

On 2024-03-13 the FDA classified a Class II recall of X3 TRIATHLON CS INSERT NO 3 10 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-1259-2024
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 3 10 MM

Reason

Potential packaging breaches of inner blister and outer sterile blister.

Identifiers

code_infoPart No. 5531-G-310-E; GTIN: 07613327390544; Lot No. 313JA9, 8711AV, A4462V, XD1AT4, MR77W5, TD5KL3, H97AME, YW30KL; Expiration Date: 10/07/2028.

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-1259-2024%22

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