FDA recall Z-0644-2022

Howmedica Osteonics Corp. · Class II · device

Product

32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032

Reason for recall

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Distribution

Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.

Key facts

Status
Ongoing
Initiation date
2021-12-21
Report date
2022-02-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0644-2022