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PLS
SINTEA PLUSTEK SRL · Model PLS-435T58 · UDI-DI 08033726409132
2
510(k) clearances
14,567
Adverse events (40 deaths)
68
Recalls
322
Facilities
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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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.