Medtronic Set Screw Retaining Driver Recalled Due to Component Sizing Issue
Medtronic is recalling seven Set Screw Retaining Drivers because oversized retaining tabs may prevent proper mating with set screws.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a functional failure in a surgical instrument where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling seven units of the Set Screw Retaining Driver (Ref 9010000820). This is an orthopedic manual surgical instrument used in medical procedures.
The recall was initiated because the retaining tabs component of the device may be oversized. This defect prevents proper mating between the Set Screw Retaining Driver and the set screw, potentially compromising the instrument's function during use.
The affected units were distributed in the United States to the states of California, North Carolina, Texas, Indiana, New Jersey, and Michigan. The specific lot code for the recalled items is TI13J01811. Healthcare facilities and users should stop using these instruments and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- TI13J01811
Distribution
Related recalls
Same manufacturer · Medtronic Sofamor Danek USA Inc
See all →- HighExpandable spinal cages recalled because they may lose height or collapse
FDA (Devices) · 2025-12-03
- HighGrafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue
FDA (Devices) · 2023-11-01
- HighGrafton Plus DBM Paste medical device recalled for packaging inspection failure
FDA (Devices) · 2023-11-01
- ModerateGrafton DMB Matrix bone graft recalled for potential outer pouch defects
FDA (Devices) · 2023-11-01
- HighGrafton DBM Demineralized Bone Matrix Recall Due to Sterile Packaging Inspection Failure
FDA (Devices) · 2023-11-01
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07