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SONTEC 5D ARCULATE MARKER
SONTEC INSTRUMENTS, INC. · Model T12-8502 · UDI-DI 00192896097100
HMQ
Prescription
0
510(k) clearances
1
Adverse events
1
Recalls
59
Facilities
Description
SONTEC 5D ARCULATE MARKER WITH ALIGNMENT NOTCHES ROUND HANDLE TITANIUM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
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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.