FDA-Device2015-08-26Class II
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
Stryker Howmedica Osteonics Corp.
Hazard
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Sold states
Worldwide Distribution.
Affected count
16992 total
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2428-2015Don't want to check this manually?
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