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CASSATT SIJ Fixation System
CTL Medical Corporation · Model 133.2260 · UDI-DI 00841732145719
1
510(k) clearances
1,410
Adverse events (5 deaths)
2
Recalls
159
Facilities
Description
D12.5 x L60mm, CT45, Lag-Loc Screw, Cannulated
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | SI-BONE, Inc. | The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
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