ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head...
FDA Recall #Z-1681-2016 — Class II — May 4, 2016
Product Description
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
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
50
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
LOT: 63275969
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated