Recall archive / FDA device enforcement
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use ... — FDA record Z-0150-2023
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 Sep 20, 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
- STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
- Reason
- Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
- Classification
- Class II
- Recalling firm
- Ethicon, Inc.
- Quantity
- 2,280 eaches
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0150-2023
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: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution of the country of China.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 9, 2022
- Recall initiation date
- Sep 20, 2022
- Center classification date
- Oct 31, 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.