—#144468

Product

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.

FDA product code: DZL — Screw, Fixation, Intraosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K031807
Affected lot / code info: Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833E, Lot numbers: 9958565, 9951621, 9952976, 9955377, 9962314, 9968868, 9969645

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 Synthes Avenue, Monument, CO 80132. A copy of the completed verification section is to sent to DePuy Synthes by: Fax 877-931-0643 or scan/email Synthes8097@stericycle.com.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-02-23
Posted by FDA: 2016-04-05
Terminated: 2016-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144468. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.