Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neu

FDA device recall Z-1326-2016 · posted 2016-04-05 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DZL

Quantity affected

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.

Date initiated

2016-02-23

Date posted

2016-04-05

Date terminated

2016-09-08

Location

West Chester, PA

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