Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Reason for recall: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device. Distribution: US Nationwide distribution in the states of CA and UT. Quantity: 163 kits Lot/code info: UDI-DI 10198459538827 Kit Lots 26DMB644 26CMC467
10198459538827
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.