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Premium UNIFY PGA Sutures

APPLIED DENTAL, INC. · Model PMG-418R16 · UDI-DI 00814639022728

GAM

510(k) clearances

57,611

Adverse events (88 deaths)

135

Recalls

145

Facilities

Description

Premium UNIFY PGA Sutures, Med 4-0, 16mm 3/8 Circle Rev Cut, 18"

Recalls

Date	Firm	Reason
2026-09-17	Henry Schein Inc.	Products lack 510(k) clearance.
2026-09-17	Henry Schein Inc.	Products lack 510(k) clearance.
2026-09-17	Henry Schein Inc.	Products lack 510(k) clearance.
2026-09-17	Henry Schein Inc.	Products lack 510(k) clearance.
2026-09-17	Henry Schein Inc.	Products lack 510(k) clearance.
2026-06-24	Covidien, LP	Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v
2026-06-24	Covidien, LP	Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v
2024-09-25	Ethicon, Inc.	Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the pack
2024-05-10	Ethicon, Inc.	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-05-10	Ethicon, Inc.	Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

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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.