Device product
Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.
Z-0178-2023
Product summary
- Event
- Event 90848
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-0178-2023
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 00615521003920, Lot Number: 10-22-140
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.