TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x… recallZ-3044-2011 · Medtronic Sofamor Danek USA Inc · initiated Jul 12, 2011
Terminated All recalls posted in August 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Screws are 5 mm longer than the size etched on the screw.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-3044-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 12, 2011
- Posted by the FDA
- Aug 19, 2011
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 17 units
- Product code
- KWP
- FDA submissions
- K984522
- Distribution
- Nationwide Distribution (USA) including the states of: OH, NY, and WI
Product description
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.
Code information (models, lots, serial numbers)
Lot number 0149857W
Other devices under the same FDA submission
1 device cleared under K984522 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TSRH® Spinal System 8372645Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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