M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 002253...
FDA Recall #Z-1678-2016 — Class II — May 4, 2016
Product Description
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
Reason for Recall
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Recalling Firm
Zimmer Manufacturing B.V. — Mercedita, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
219
Distribution
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
Code Information
LOTS: 63295051 63293672
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated