Z-0180-2023 Class II Terminated
FDA device recall Z-0180-2023 was initiated by Baxter Healthcare Corporation on Sep 20, 2022 and is designated Class II. 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. The recall status is terminated (terminated Aug 4, 2026). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 9, 2022
- Initiation Date
- Sep 20, 2022
- Termination Date
- Aug 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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.
Distribution Pattern
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
Code Information
UDI/DI 00615521012731, Lot Number: 22-124
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0180-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026