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Hyundae Meditech Co., Ltd. · Model FCL19100E160 · UDI-DI 08800056424223
NEW
Prescription
1
510(k) clearances
16,087
Adverse events (41 deaths)
40
Recalls
86
Facilities
Description
Determined based on the confidentiality designation assigned to the proprietary brand name associated to the listing number in the Device Registration and Listing Module(DRLM) database. In order to make changes to the Public Release status, please review your confidentiality designation in DRLM.
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.