32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
FDA Recall #Z-0644-2022 — Class II — December 21, 2021
Product Description
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.
Recalling Firm
Howmedica Osteonics Corp. — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8 units
Distribution
Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.
Code Information
UDI: 07613327012842; Lot Number: 87327407
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated