FDA-Device2024-01-10Class II
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Encore Medical, LP
Hazard
Mislabeling
Sold states
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
Affected count
17 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0625-2024Don't want to check this manually?
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