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
Product summary
- 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
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.