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Extremities, Large Kit Assy, US, 15/3 - Product Usage: is… recallZ-2389-2020 · Medtronic Sofamor Danek USA Inc · initiated Apr 24, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected], and contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.

Recall details

Recall number
Z-2389-2020
Status
Terminated
Initiated by the company
Apr 24, 2020
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
41 units
Product code
HRX
FDA submissions
K010246, K041454, K981251
Distribution
Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.

Product description

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.

Code information (models, lots, serial numbers)

Product number: EL153B;   GTIN: 00643169157248;   Lot Number: 0009541707

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

36 devices cleared under K010246, K041454, K981251 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85611).

Sources and updates

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