PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 27, 2016 Initiated: January 6, 2016 #Z-1524-2016

Product Description

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

Reason for Recall

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).

Details

Units Affected
30 units of Lot # 9666776 and 11 units of Lot # 9671879
Distribution
Worldwide Distribution - US Nationwide in the states of NC, CA, NY, TX, NJ, CO and the countries of: Ontario and Canada.
Location
West Chester, PA

Frequently Asked Questions

What product 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. Recalled by Synthes (USA) Products LLC. Units affected: 30 units of Lot # 9666776 and 11 units of Lot # 9671879.
Why was this product 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).
Which agency issued this recall?
This recall was issued by the FDA Devices on April 27, 2016. Severity: Moderate. Recall number: Z-1524-2016.