primaLOK SP
Wenzel Spine, Inc. · Model 800-0828-00 · UDI-DI 00813210021785
Description
primaLOK SP 28mm Medium Boxless Implant, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2023-02-16 | Medtronic Sofamor Danek USA Inc | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| 2022-06-13 | K2M, Inc. | Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irrit |
| 2022-01-13 | K2M, Inc | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lot |
| 2022-01-13 | K2M, Inc | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lot |
| 2020-03-26 | Medtronic Sofamor Danek USA Inc | Nonconforming product; length of the product measured shorter than the labeled length. |
| 2020-01-28 | Medicrea International | An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the re |
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