FDA-Device2022-11-09Class II

Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.

Hazard

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.

Sold states
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
Affected count
13 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2023

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