FDA recall Z-1263-2024

Howmedica Osteonics Corp. · Class II · device

Product

NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Reason for recall

Potential packaging breaches of inner blister and outer sterile blister.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-02-06
Report date
2024-03-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1263-2024