FDA Device recall Z-0180-2023
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101
- FDA Device
- Class II
- terminated
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101 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-0180-2023 |
| 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
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
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 00615521012731, Lot Number: 22-124 |
|---|
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-0180-2023%22
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