Product 6 consists of all products under product code HWC, and same usage: Item no: 474935010...
FDA Recall #Z-1104-2016 — Class II — January 11, 2016
Product Description
Product 6 consists of all products under product code HWC, and same usage: Item no: 47493501001 3.5 X 10 CORT SCREW SELFT 47493501801 3.5 X 18 CORT SCREW SELFT Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Reason for Recall
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
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
12
Distribution
US Nationwide Distribution
Code Information
lot no: 61851308 61851309
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated