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Stryker's STAR Ankle Replacement Device Gets FDA Safety Advisory

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The FDA issued a safety advisory on Stryker Corporation’s (NYSE: SYK) Scandinavian Total Ankle Replacement devices, also known as STAR Ankle, citing the risk of a plastic component breaking after surgical implantation.

  • According to the FDA, the plastic component may break as soon as three to four years after the device is inserted, leading to surgery to repair or replace the device.

  • The agency noted that plastic component fractures in the device might be attributed to multiple issues, including the component’s thickness, the degradation of the material, surgical factors, and patient factors, such as younger patients with higher activity levels.

  • The FDA believes the STAR Ankle remains appropriate for certain patient populations, such as older patients with lower activity levels. 

  • The STAR Ankle is indicated for use as an artificial joint and used to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis.

  • Price Action: SYK shares closed 0.1% at $241.25 on Monday.

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