Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-1524-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 6, 2016

Date Posted: April 27, 2016

Recall Number: Z-1524-2016

Event ID: 73549

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).

Status: Terminated

Product Quantity: 30 units of Lot # 9666776 and 11 units of Lot # 9671879

Code Information:

Lot # 9666776 (catalog ID 450.136) and 9671879 (catalog ID 450.016)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated