International safety notice

Urgent Field Safety Notice for PDS II (polydioxanone) Suture; PDS Plus Antibacterial (polydioxanone) Suture; PROLENE Polypropylene Suture; ETHIBOND EXCEL Polyester Suture by Ethicon, LLC

Germany / BfArM · DEU · Mar 12, 2025

Key facts

Title Urgent Field Safety Notice for PDS II (polydioxanone) Suture; PDS Plus Antibacterial (polydioxanone) Suture; PROLENE Polypropylene Suture; ETHIBOND EXCEL Polyester Suture by Ethicon, LLC
Regulator Germany / BfArM
Country DEU
Brand PDS II (polydioxanone) Suture; PDS Plus Antibacterial (polydioxanone) Suture; PROLENE Polypropylene Suture; ETHIBOND EXCEL Polyester Suture
Manufacturer Ethicon, LLC
Models 10705031060227, 8711H, 10489X, 104JPJ, X843H, PDP127H, 104BQC, 10705031058088, 8706H, 104DA2, 104BQ0, 104JAR and 11 more
Date Mar 12, 2025
Regulator page bfarm.de

At a glance

  • No Recall
  • No Field safety notice

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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