Z-0314-2022 Class II Ongoing
FDA device recall Z-0314-2022 was initiated by Howmedica Osteonics Corp. on October 15, 2021 and is designated Class II. Reason for recall: There is a potential for the outer white Tyvek lid to debond from the sealed package. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- December 8, 2021
- Initiation Date
- October 15, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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 Pattern
Puerto Rico
Code Information
UDI number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306