Medtronic Bone Void Filler, Small - 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 is recalling Medtronic Bone Void Filler, Small (Product number C07A, Lot Number 1127301) because the product may not maintain its setting characteristics for the labeled shelf-life duration. This bone void filler is an injectable, moldable calcium phosphate material used during surgery to fill bone voids. The defect could cause the product to take longer to set during implantation, potentially extending surgical and anesthesia time for the patient.
If the device seeps or creeps from its intended position before it sets, it may result in incomplete filling of the bone void or gap. This could lead to longer-term complications including incomplete bone formation, lack of bone formation, delayed union, or nonunion. A total of 36 units were distributed nationwide to California, Florida, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia, and Washington. The source does not specify what 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: 36 units Lot/code info: Product number: C07A; GTIN: 00813845020504; Lot Number: 1127301
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.