Simple Clamp — Class II medical device recall Z-0180-2023
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-0180-2023 |
|---|---|
| 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 | 1 units |
| UPC / GTIN / UDI-DI | 00615521012731 |
| Lot numbers | 22-124 |
| Model numbers | 800101, F-40018 |
Product
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.
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-0180-2023. 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.