FDA recall Z-2616-2023

Product

PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16

Reason for recall

Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

Distribution

US Nationwide. Global Distribution.

Key facts

Status

Ongoing

Initiation date

2023-08-10

Report date

2023-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Guaynabo, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2616-2023