Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
FDA Recall #Z-1675-2016 — Class II — May 4, 2016
Product Description
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
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
200
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: 63297474
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated