Z-2985-2011

ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). Medtronic...

Name: Z-2985-2011 ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). Medtronic...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2011-07-06
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2011-07-06 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). Medtronic Sofamor Danek USA, Inc. This instrument is a... on 2011-07-06. The reason FDA records is "Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2985-2011
Status: Terminated
Initiated: 2011-07-06
Posted: 2011-08-10
Terminated: 2013-04-26
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function.
Product code: XLH
Reason for recall: Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic Sofamor Danek USA, Inc. sent "Voluntary Recall - Medtronic" letters on July, 2011 to all affected customers. The letter included; description of product and problem, and asked customers to stop using the product. Customers are asked to contact their Sales Representatives for replacement. For question on this recall call Medtronics Global Quality Department at (800) 876-3133.
Quantity in commerce: 191 units
Distribution: Worldwide Distribution: Nationwide distribution including the states of MN, OK, IL, AK, CA, PA, UT, LA, SC, NY, MI, GA, WI, KY, AL, MO, AZ, TN, TX, MA, NE, OH, FL, CO, MT, CT, VA, NC, NH, WA, WV, WY, IN, IA, KS, MT, ME, DE, DC, NJ, MD, MS, NV, HI, ID, ND, and AR; and the country of Uruguay.
Product codes and lots: **All lots.

Product code XLH

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)