Zimmer Biomet, Inc. recalls Modular Head Component, Biomet Hip System; Item No. 11-36366
Recalled Product
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Hazard / Issue
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
Issued by
FDA
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