Medtronic Bone Void Filler, Large - 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, Large (Product number C07B, Lot Number 1127302), an injectable calcium phosphate bone void filler used during surgery to fill bone voids. The 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. Six units were distributed nationwide to California, Florida, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia, and Washington.
If the product seeps or moves from its intended position before setting completely, it may result in incomplete filling of the bone void or gap. This could potentially lead to incomplete bone formation, lack of bone formation, delayed bone union, or nonunion in the longer term. The recall source does not specify a remedy or action for affected consumers to 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: 6 units Lot/code info: Product number: C07B; GTIN: 00813845020511; Lot Number: 1127302
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.