FDA-Device2015-08-26Class II

Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.

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
Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2429-2015

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