Recall Z-1326-2016 ยท DZL Screw, Fixation, Intraosseous
Synthes (USA) Products LLC
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
| Date | Apr 5, 2016 (initiated Feb 23, 2016) |
| Status | Terminated |
| Reason | Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized. |
| Root cause | Nonconforming Material/Component |
| Action | DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated February 23, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were notified by mail of a potential patient impact. They were instructed to review existing inventories and call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization (RA) Number and replacement order. After completing the verification section on page 4 of the letter, they were advised to return the verification section (page 3) with the product to Credit/Returns, DePuy Synthes, 1101 Sy |
| Quantity | 500 units distributed in USA, and 35 units distributed OUS |
| Distribution | Worldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of Canada and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031807 | SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS Synthes (Usa), Jul 2, 2003 |