Recall Z-2616-2023— ETHICON, LLC
Class II · Ongoing
Class II FDA medical device recall by ETHICON, LLC, initiated 2023-08-10. FDA's recall record names no specific 510(k) clearance for this event. 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: Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement..
- Recalling firm
- ETHICON, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-10
- Firm location
- Guaynabo, PR, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.