Mac Pin Non-Cannulated Screw…

Date

Jan. 17, 2018

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Amendia, Inc

Product

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Reason

Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

Distribution pattern

Distribution to Georgia, USA.

Quantity

41 screws

Codes and lots

Model #85-6560-1, Lot #132117

Recall started

July 7, 2017

Device type

Thoracolumbosacral Pedicle Screw System

Root cause (FDA)

Process control

What the company told customers

Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.

Recall number

Z-0325-2018

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0325-2018. The agency record governs; check it and the company before acting.