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Encore Medical, LP recalls RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Recalled November 15, 2023 · FDA recall Z-0282-2024 · Encore Medical
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. · FDA Class II
Units
20
Sold at
US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Description
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.
Product
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Manufacturer(s)
Encore Medical, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →