Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical
Check against the official notice below — it lists the full affected range.
Signature Orthopedics Pty Limited is recalling 10 units of Signature Ceramic Femoral Head model 111-152-621 due to mislabeling. The ceramic femoral heads in this batch are packaged with labels that do not match the actual component size inside, meaning the product needed for a surgical procedure may not be included in the packaging. This mislabeling could result in surgical delays while replacement product is located.
The affected product was distributed worldwide, including throughout the United States and Australia. The recalled units are identified by UDI 09348215001926 and lot number 78560. The source record does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.
Reason for recall: This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved. Distribution: Worldwide Distribution - U.S. Nationwide and the country of Australia. Quantity: 10 Lot/code info: UDI: 09348215001926. Lot:78560.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.