FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: 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.
- Recall number
- Z-2389-2020
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2020-04-24
- Posted
- not on file
- Terminated
- 2021-03-31
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Medtronic notified customers on about 04/24/2020 via "URGENT: Voluntary Market Removal (Recall)" letter. Customers were informed that Medtronic was notified by Skeletal Kinetics LLC that product that may not maintain its setting characteristics for the labeled shelf-life duration of the product, which may lead to a longer period of time required for the product to set at the time of implantation. Instructions included to not use the product and locate and removed the impacted product from inventory, complete the provided Customer Confirmation Form and return it via email to rs.sdmriskmgt@medtronic.com, and contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.
- Quantity
- 41 units
- Distribution
- Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.
- Lot, serial or model codes
- Product number: EL153B; GTIN: 00643169157248; Lot Number: 0009541707
- 510(k) numbers
- ["K010246","K041454","K981251"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28