Recall archive / FDA device enforcement
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles — FDA record Z-1773-2022
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 Aug 8, 2022. 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 II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
- Reason
- Product may contain the incorrect material which could impact treatment.
- Classification
- Class II
- Recalling firm
- Ethicon, Inc.
- Quantity
- 88 boxes (1056 ea)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1773-2022
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 (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box) Product Number: Z771D; Lot No: SAMPAL |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution in Japan only
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 28, 2022
- Recall initiation date
- Aug 8, 2022
- Center classification date
- Sep 20, 2022
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.