FDA recall Z-0314-2022
Howmedica Osteonics Corp. · Class II · device
Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Reason for recall
There is a potential for the outer white Tyvek lid to debond from the sealed package.
Distribution
Puerto Rico
Key facts
- Status
- Ongoing
- Initiation date
- 2021-10-15
- Report date
- 2021-12-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mahwah, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0314-2022