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Screw, Cann., 7.0mmx125mm, 24mm Thread

Pioneer Surgical Technology, Inc. · Model 431-694-125 · UDI-DI 00846468042141

OURHWC Prescription
10
510(k) clearances
1,410
Adverse events (5 deaths)
2
Recalls
159
Facilities

Description

7.0mmx125mm, 24mm Thread

Recalls

DateFirmReason
2026-08-21SI-BONE, Inc.The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
2025-11-03Orthofix U.S. LLCLabeling contains claims that are not consistently present.

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Data 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.