FDA-Device2023-12-27Class II
LITe Decompression Snake Arm, REF 48080230
Stryker Spine
Hazard
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
Sold states
US: MD, MI, NM, TX & OUS: Canada & France.
Affected count
9
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
LITe Decompression Snake Arm, REF 48080230
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0610-2024Don't want to check this manually?
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