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ASSUFIL MONOFILAMENTO
ASSUT EUROPE SPA · Model 5FV60MHYSO · UDI-DI 08033439168449
1
510(k) clearances
15,865
Adverse events (41 deaths)
40
Recalls
86
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-15 | ETHICON, LLC | Potential for barb non-engagement. |
| 2025-03-07 | Ethicon Endo Surgery, LLC | Identified curing issues with the silicone during the needles manufacturing process. |
| 2025-03-07 | Ethicon Endo Surgery, LLC | Identified curing issues with the silicone during the needles manufacturing process. |
| 2025-03-07 | Ethicon Endo Surgery, LLC | Identified curing issues with the silicone during the needles manufacturing process. |
| 2025-03-07 | Ethicon Endo Surgery, LLC | Identified curing issues with the silicone during the needles manufacturing process. |
| 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 . |
| 2023-08-10 | ETHICON, LLC | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. |
| 2023-08-10 | ETHICON, LLC | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. |
| 2023-03-31 | Ethicon, Inc. | Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be |
| 2022-11-16 | Ethicon, Inc. | knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operat |
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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.