Recall archive / FDA device enforcement
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/... — FDA record Z-1053-2022
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 Mar 24, 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 sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
- Reason
- Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
- Classification
- Class II
- Recalling firm
- Ethicon, Inc.
- Quantity
- 2808 (all OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1053-2022
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 | Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of China.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 18, 2022
- Recall initiation date
- Mar 24, 2022
- Center classification date
- May 10, 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.