SPIN
NEWDEAL · Model 112114SND · UDI-DI 10381780047469
HWC
Prescription
10
510(k) clearances
58,942
Adverse events (75 deaths)
388
Recalls
657
Facilities
Description
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-24 | Medartis AG | The cannulation of the CCS screw is not centered. |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2025-11-24 | Smith & Nephew, Inc. | Removal of affected lot of screws due to labeling error. |
| 2024-04-12 | Medartis Inc. | Screw is 16mm long instead of 22mm long. |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.