Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0180-2023

September 20, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90848
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0180-2023

Official wording

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.

Code information: UDI/DI 00615521012731, Lot Number: 22-124

Distribution pattern: MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.