Device product
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Z-0644-2022
Product summary
- Event
- Event 89456
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-0644-2022
Official wording
Reason: There is a potential for the outer Tyvek lid to de-bond from the sealed package.
Code information: UDI: 07613327012842; Lot Number: 87327407
Distribution pattern: Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.
Derived failure modes
-
Unknown
There is a potential for the outer Tyvek lid to de-bond from the sealed package.