Recall Z-1524-2016 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Synthes (USA) Products LLC
Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879
| Date | Apr 20, 2016 (initiated Jan 6, 2016) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Packaging process control |
| Action | DePuy Synthesis sent an Urgent Notice Medical Device Recall letter dated January 6, 2016 to customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers to complete and return the attached Verification Section (page 3 of the letter). For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant. |
| Quantity | 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. |
| FDA record | Open on fda.gov |