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NorthStar
Seaspine Orthopedics Corporation · Model PC1-313530 · UDI-DI 10889981320249
1
510(k) clearances
2,190
Adverse events (15 deaths)
6
Recalls
169
Facilities
Description
Ext Tab Smooth Shank Screw, 3.5mm x 30mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-14 | K2M, Inc | The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length). |
| 2020-11-03 | K2M, Inc | Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or resul |
| 2019-09-16 | Synthes (USA) Products LLC | The subject product measures 4.0mm in diameter instead of 3.5mm. |
| 2018-07-24 | K2M, Inc | Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retr |
| 2018-02-23 | Orthofix, Inc | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affect |
| 2018-02-23 | Orthofix, Inc | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affect |
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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.