Z-1869-2013Class II

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

Name: Z-1869-2013 Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized...
Creator: SpineFrontier, Inc.
Published: 2012-10-05
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2012-10-05 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of 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... on 2012-10-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1869-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-05
Posted: 2013-08-01
Terminated: 2015-07-29
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: 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
Product code: FSM Tray, Surgical, Instrument
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 11 caddies
Distribution: US distribution in states of: CO, DC, MA and TX.
Product codes and lots: 31176, 018652, 018645R, 42011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1869-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1869-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)