FDA Device Intelligence
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Suture, Nonabsorbable, Synthetic, Polyethylene

FDA product code GAT · Class 2 · General, Plastic Surgery

9,265
Registered devices
20,010
Adverse events
23
Recalls
175
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-12-02Covidien, LPSterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
2022-12-02Covidien, LPSterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
2022-12-02Covidien, LPSterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
2022-12-02Covidien, LPSterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
2019-08-15Musculoskeletal Transplant Foundation, Inc.Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.
2019-02-21ArthroCare CorporationThe voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage
2015-04-30Smith & Nephew, Inc.Sterility of device maybe compromised
2014-06-25Peters SurgicalA potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
2014-06-25Peters SurgicalA potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
2014-03-11Teleflex MedicalThe products are being recalled because they did not meet minimum needle attachment strength requirements.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.