Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2020 - (Recall #: Z-2391-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 24, 2020

Date Posted: June 24, 2020

Recall Number: Z-2391-2020

Event ID: 85611

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.

Status: Terminated

Product Quantity: 6 units

Code Information:

Product number: C07B; GTIN: 00813845020511; Lot Number: 1127302

Distribution Pattern:

Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.

Voluntary or Mandated:

Voluntary: Firm initiated