Recall Z-1571-2023 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon, Inc.
PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
| Date | May 10, 2023 (initiated Mar 31, 2023) |
| Status | Open, Classified |
| Reason | Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved |
| Root cause | Under Investigation by firm |
| Action | Ethicon issued Urgent Field Safety Notice Voluntary Product Recall (Removal) Letter for Johnson & Johnson Affiliates in the countries to contact primary and secondary consignees and/or end customers. Letter issued via email 3/31/23, states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs |
| Quantity | 1,656 eaches (OUS only) |
| Distribution | International distribution in the countries of United Kingdom, Ireland and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061037 | PDS PLUS ANTIBACTERIAL SUTURE ETHICON, Inc., Jul 14, 2006 |