FDA-Device2023-11-15Class II
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Encore Medical, LP
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 Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0281-2024Don't want to check this manually?
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