Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within

FDA device recall Z-1869-2013 · posted 2013-08-01 · Terminated

Recall details

Recalling firm

SpineFrontier, Inc.

Reason for recall

Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.

Action taken

The firm, SpineFrontier, sent an Advisory Notice entitled "URGENT May 1, 2013, PedFuse Screw Caddy Removal" dated May 1, 2013 to their consignees/customers. The notice described the product, problem and action to be taken. Consignees/customers were informed that a removal has been initiated to remove the parts from the field to ensure that all sets contain correctly marked screw caddies. Consignees/customers wre instructed to complete and return the URGENT PedFuse Screw Caddy Removal ACKNOWLEDGEMENT FORM via fax to: SpineFrontier, Inc., 978-232-3991 or email: customerservice@spinefrontier.com. Replacement caddies will be shipped upon receipt of completed acknowledgement form and RMA request for part return. Please feel free to contact SpineFrontier at 978-232-3990 with any questions.

Root cause

Device Design

Status

Terminated

Product code

FSM

Quantity affected

11 caddies

Distribution

US distribution in states of: CO, DC, MA and TX.

Date initiated

2012-10-05

Date posted

2013-08-01

Date terminated

2015-07-29

Location

Beverly, MA