CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report

Extremities, Large Kit Assy, US, 15/3 recalled

Medtronic Sofamor Danek USA is recalling Extremities, Large Kit Assy, US, 15/3, distributed nationwide in the US. The recall was initiated on 24 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct number: EL153B; GTIN: 00643169157248; Lot Number: 0009541707

Quantity recalled41 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2389-2020
FDA event ID: 85611
Recalling firm: Medtronic Sofamor Danek USA, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2020
FDA classified: 16 Jun 2020
Reported: 24 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

24 Apr 2020	Recall initiated by company
16 Jun 2020	Classified by FDA	+53 days
24 Jun 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide California Florida Illinois Indiana Kentucky Minnesota Missouri Montana Ohio Pennsylvania Texas Virginia Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 85611

This product is part of a recall event; the main page for the event is Medtronic Bone Void Filler, Small recalled.

Reported	Class	Recall	Company	Reason	Where
24 Jun 2020	CLASS II	Medtronic Bone Void Filler, Small recalled	Medtronic Sofamor Danek USA	Device Malfunction	Nationwide
24 Jun 2020	CLASS II	Medtronic Bone Void Filler, Large recalled	Medtronic Sofamor Danek USA	Device Malfunction	Nationwide

More recalls from Medtronic Sofamor Danek USA

All 77

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS II	Catalyft PL & PL40 Expandable Interbody System labeled as recalled	Medtronic Sofamor Danek USA	Other	Nationwide
1 Nov 2023Device	CLASS II	Grafton DBM Crunch recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Matrix Strips recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Putty recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton Plus DBM Paste recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide