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Terminated

Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients

FDA Recall Z-1869-2013 · Posted 2013-08-01

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeFSM
Date Initiated2012-10-05
Date Terminated2015-07-29
Product Quantity11 caddies

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.

Firm Action

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: [email protected]. 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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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