Recall archive / FDA device enforcement
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position... — FDA record Z-0177-2023
Reported terminated
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
- Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.
- Reason
- the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 2 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0177-2023
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 00615521002725, Lot Number: 22-123 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
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
- Nov 9, 2022
- Recall initiation date
- Sep 20, 2022
- Center classification date
- Nov 3, 2022
- Termination date
- Aug 4, 2026
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.