FDA-Device2023-11-15Class II
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Hazard
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
Sold states
US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Affected count
20
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2024Don't want to check this manually?
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