Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert ...
FDA Recall #Z-1680-2016 — Class II — May 4, 2016
Product Description
Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007
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
90
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: 63303808 63292589 63292588
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated