Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
FDA Recall #Z-0645-2022 — Class II — December 21, 2021
Product Description
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
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
1 unit
Distribution
Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.
Code Information
UDI: 07613327013306; Lot Number: 87458602
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated