Zimmer Biomet—GPS III and Plasmax Kits: Manufacturer Reminds Customers to Use Products in Accordance with 510(k) Indications for Use
September 5, 2018 | Strategic Insights for Health System
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In an August 23, 2018, Urgent Medical Device Correction letter submitted by ECRI Institute member hospitals, Zimmer Biomet states that certain components of the above products may be used to create an output called "lnterleukin-1 receptor agonist protein" (IRAP) for injection, which is an off-label use of these products. In addition to the term IRAP, this output is sometimes referred to as "autologous protein solution" (APS) or "Interleukin receptor agonist" (ILRA). Zimmer Biomet also states that the above products...