Recall archive / FDA device enforcement
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740. — FDA record Z-1572-2022
Reported completed
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 Jun 3, 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
- SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
- Reason
- The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
- Classification
- Class II
- Recalling firm
- SAFE ORTHOPAEDICS LLC
- Quantity
- 8 devices
- Agency-reported status
- Completed
- Source record identifier
- Z-1572-2022
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 | KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made to MD. There was no government/military distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 31, 2022
- Recall initiation date
- Jun 3, 2022
- Center classification date
- Aug 24, 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.