March 05, 2013
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Biomet UK issues field safety notice for oversized knee system

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Biomet UK Ltd recently issued a field safety corrective action for its RHK Axle and RHK Short Hinge and RHK Long Hinge Assembly components manufactured before January 2013, citing an oversized diameter axle that would have made it impossible for surgeons to put the axle and yoke together. Surgeons with one of these components would need to delay surgery until a replacement part is located or would be unable to complete the surgery, according to the safety notice.

Following a customer complaint that the axle would not enter the yoke of an RHK Short Hinge Assembly component, Biomet UK completed an investigation and confirmed that the axle component was oversized. This component was not sold in the United States, according to a Biomet UK representative.

Biomet UK recommended the following reference numbers be discontinued and returned to them as soon as possible:

  • 154998 – All items with a use by date prior to 2023-01
  • 161583 – All items with a use by date prior to 2018-01
  • 161584 – All items with a use by date prior to 2018-01

A representative from Biomet UK told Orthopedics Today that none of these implants were put in patients and that an orthopedic consult would only be able to complete the procedure if the component did not have the dimensional discrepancy.

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“In accordance with the applicable regulatory requirements, Biomet issued a Field Safety Notice to the hospitals involved in order to retrieve all potentially affected components from the market,” a representative from Biomet UK told Orthopedics Today. “Corrective action has been taken to minimize the risk of re-occurrence of the reported matter.”

Reference:
http://www.bfarm.de/SharedDocs/1_Downloads/EN/medDev/fca/11/2013/7959-12_Download_en.pdf?__blob=publicationFile