Recall archive / FDA device enforcement
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use... — FDA record Z-1571-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 31, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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
- Classification
- Class II
- Recalling firm
- Ethicon, Inc.
- Quantity
- 1,656 eaches (OUS only)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1571-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the countries of United Kingdom, Ireland and Turkey.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 17, 2023
- Recall initiation date
- Mar 31, 2023
- Center classification date
- May 10, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.