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.
Reported: November 9, 2022 Initiated: September 20, 2022 #Z-0180-2023
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 1 unit
- Distribution
- MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corporation. Units affected: 1 unit.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 9, 2022. Severity: Moderate. Recall number: Z-0180-2023.
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