PDS (Polydioxanone) Monofilament Suture

Returned representative unopened samples were evaluated for knot tensile strength and a portion of samples were observed to be significantly below the minimum knot tensile force requirement. Low suture tensile strength may result in poor performance of the impacted product. The intended benefit of tissue approximation and/or ligation may not be achieved or sustained. Because the knot tensile strength was observed to be significantly below the force requirement, there is a high likelihood that if this issue is present, it will result in breakage prior to use or intra-operatively rather than premature post-operative breakage.

Recall start date: November 15, 2022