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Recall Observatory FDA recall evidence

Device product

X3 TRIATHLON CS INSERT NO 7 9 MM

Z-1262-2024

February 06, 2024

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 94026
Status
Ongoing
Classification
Class II
Quantity
24 units (US)
Official record key
device-enforcement:Z-1262-2024

Official wording

Reason: Potential packaging breaches of inner blister and outer sterile blister.

Code information: Part No. 5531-G-709-E; GTIN: 07613327337464; Lot No. KA1Y71; Expiration Date: 11/08/2028.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential packaging breaches of inner blister and outer sterile blister.