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SImmetry Implant, 12.5mm x 30mm
Paradigm Spine GmbH · Model 10-P12530-01 · UDI-DI 04260636674907
OUR
Prescription
1
510(k) clearances
1,408
Adverse events (5 deaths)
2
Recalls
159
Facilities
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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