FDA Device recall Z-0177-2023
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103
- FDA Device
- Class II
- terminated
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103 by Baxter Healthcare, citing 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 integri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0177-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-20 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | MI, TX, WA, WI |
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.
Identifiers
| code_info | UDI/DI 00615521002725, Lot Number: 22-123 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0177-2023%22
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