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FS3 Facet Screw Spinal System
Life Spine, Inc. · Model 144-45-25 · UDI-DI 00190837003722
MRW
Prescription
1
510(k) clearances
105
Adverse events
4
Recalls
100
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-27 | Medtronic Sofamor Danek USA, Inc | Product is impacted by a thread profile defect due to a manufacturing issue. |
| 2011-06-07 | Osteomed, Lp | Two of the Implant Driver Assembly tips were reported to break during surgery. |
| 2011-03-15 | Interventional Spine Inc | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver ra |
| 2011-03-15 | Interventional Spine Inc | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver ra |
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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.