Z-2878-2011

ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place...

Name: Z-2878-2011 ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2011-06-28
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2011-06-28 / Terminated

FDA source

Medtronic Sofamor Danek USA Inc began a recall of ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide... on 2011-06-28. The reason FDA records is "Screws are longer then size etched on the screw". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2878-2011
Status: Terminated
Initiated: 2011-06-28
Posted: 2011-07-25
Terminated: 2012-12-24
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Screws are longer then size etched on the screw.
FDA root cause: Other
Action: Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011. For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.
Quantity in commerce: 101 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of MN, AK, FL, PA, ME, GA HI, CA, TX, OH, IN, MO, WI, MI, NY, IN, LA, MD, MA, NC, OR, NE WA, ID, CO, OR, UT, IL, WV, Canada, Singapore, Netherlands, Brazil, Columbia, Hong Kong, and Mexico.
Product codes and lots: Lot number H10A1268

Product code KWP

K042025Class IIModification to Cd Horizon Spinal SystemMedtronic Sofamor Danek, Inc. / cleared 2004-08-25

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)