Synthes (USA) Products LLC recalls Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex…

Recall date

January 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1524-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Worldwide Distribution - US Nationwide in the states of NC, CA, NY, TX, NJ, CO and the countries of: Ontario and Canada.

Why it was recalled

DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of 450.136 screws (4mm Cancellous Self Tapping Screw, Length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm Cortex Standard Screw, length 16 mm, lot 9671879).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879