Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Check against the official notice below — it lists the full affected range.
Medtronic Sofamor Danek USA Inc has recalled 41 units of its Extremities Large Kit Assembly bone void filler (Product number EL153B, Lot Number 0009541707) distributed nationwide to California, Florida, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia, and Washington. The injectable, moldable calcium phosphate product may not maintain its setting characteristics for the labeled shelf-life duration, which could cause it to take longer to set during implantation and increase surgical and anesthesia time for the patient.
If the device seeps or moves from its intended position before setting completely, it may create incomplete void or gap filling in the surgical site. This could result in longer-term complications including incomplete bone formation, lack of bone formation, delayed union, or nonunion. The source document does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Reason for recall: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion. Distribution: Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA. Quantity: 41 units Lot/code info: Product number: EL153B; GTIN: 00643169157248; Lot Number: 0009541707
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.