Z-3044-2011

TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA...

Name: Z-3044-2011 TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2011-07-12
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2011-07-12 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Sofamor Danek USA Inc began a recall of TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofamor Danek USA. Product Usage: TSRH(R)... on 2011-07-12. The reason FDA records is "Screws are 5 mm longer than the size etched on the screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3044-2011
Status: Terminated
Initiated: 2011-07-12
Posted: 2011-08-19
Terminated: 2012-07-20
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofamor Danek USA. Product Usage: TSRH(R) Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumber, and/or sacral spine.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Screws are 5 mm longer than the size etched on the screw.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 07/12/2011, the recalling firm, Medtronic notified the Sales Managers and Sales Force by conference call and email regarding the imminent notification and follow-up activities. A "VOLUNTARY RECALL" notification letter was sent to Risk Managers and Sales Representatives on 07/13/2011 with a delivery date of 07/14/2011. The letter states to immediately remove the recalled product from use and return to Medtronic. The letter includes a questionnaires form to be completed and returned as per the instructions. If appropriate, personal follow up with Sales Representatives will be made to assure that Risk Managers understand the recall communication and to facilitate return of product and the associated questionnaire documentation. For questions, contact your Medtronic Sales Representative or the Global Quality Department at 800-876-3133, extension 3173.
Quantity in commerce: 17 units
Distribution: Nationwide Distribution (USA) including the states of: OH, NY, and WI
Product codes and lots: Lot number 0149857W

Product code KWP

K984522Class IIModification of Tsrh Spinal SystemDanek Medical, Inc. / cleared 1999-01-06

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)