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Streamline® MIS Spinal Fixation System
Xtant Medical Holdings, Inc. · Model 51-K-WIRE · UDI-DI 00840311246830
HXI
Prescription
3
510(k) clearances
291
Adverse events
8
Recalls
156
Facilities
Description
MIS, 50cm Guidewire
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Paragon 28, Inc. | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. |
| 2016-05-20 | Integra LifeSciences Corp. | The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated |
| 2013-01-10 | Extremity Medical LLC | The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected scr |
| 2011-03-23 | Interventional Spine Inc | This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wir |
| 2011-03-23 | Interventional Spine Inc | This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wir |
| 2005-03-16 | EBI, L.P. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
| 2005-03-16 | EBI, L.P. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
| 2005-03-16 | EBI, L.P. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
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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.