FDA-Device2024-03-13Class II

NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Howmedica Osteonics Corp.
Hazard

Potential packaging breaches of inner blister and outer sterile blister.

Sold states
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Affected count
18 units (US); 5 units (OUS)
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2024

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