C-Flex Polar Head Positnr-Device Only — Class II medical device recall Z-0176-2023
Terminated recall by Baxter Healthcare Corporation, reported 2022-11-09, distributed in TX, WA, WI. the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a res
| Recall number | Z-0176-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-09-20 |
| Classified | 2022-11-03 |
| Reported by FDA | 2022-11-09 |
| Terminated | 2026-08-04 |
| Distributed | TX, WA, WI |
| Countries outside the US | DE, JP, KR, SE, ZA |
| Quantity | 2 units |
| UPC / GTIN / UDI-DI | 00615521002701 |
| Lot numbers | 122190000182, 122190001101 |
| Model numbers | 103001, A-70701 |
Product
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0176-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.