Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Num

FDA device recall Z-0191-2008 · posted 2008-03-11 · Terminated

Recall details

Recalling firm

Allez Spine, LLC

Reason for recall

Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.

Action taken

On July 30, 2007 Allez Spine notified all its field representatives and distributors via email of a potential for failure of the Size 8 Pedicle Screws when used in combination with the single piece locking nuts and instructed them to return all unused inventory of Size 8 Screws and the two piece Locking Nuts with saddle. This action was to be carried out to the retail level-hospital, clinic, lab, and physicians sold the product. The email also had an attachment of a list of expected frequently asked questions (FAQ) from surgeons and answers to help them respond. A second Notice to all users was sent by the recalling firm on Feb 29, 2008, to request follow-up of implanted units.

Root cause

Device Design

Status

Terminated

Product code

MNI

Quantity affected

14

Distribution

Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT

Date initiated

2007-07-30

Date posted

2008-03-11

Date terminated

2012-04-09

Location

Irvine, CA

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