Home › Surgical Specialties México, S. de R.L. de C.V. › Fumedica
Fumedica
Surgical Specialties México, S. de R.L. de C.V. · Model KS1-745-8-1 · UDI-DI 00848782046324
GAQ
Prescription
10
510(k) clearances
955
Adverse events (7 deaths)
8
Recalls
73
Facilities
Description
FBK-48-98-160P 7 Steel wire 8x45cm sterile 5.5 Wrapped
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-23 | Ethicon, LLC | Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional |
| 2026-09-08 | Ethicon, LLC | Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior t |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2019-04-19 | Ethicon, Inc. | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot |
| 2019-04-19 | Ethicon, Inc. | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot |
| 2014-03-11 | Teleflex Medical | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. |
| 2014-03-11 | Teleflex Medical | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. |
| 2014-03-11 | Teleflex Medical | The products are being recalled because they did not meet minimum diameter requirements. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.