CLASS II Device recall · Reported 5 May 2021 · FDA Enforcement Report

InCore Lapidus Disposable Kit Right recalled by Nextremity Solutions

Nextremity Solutions is recalling InCore Lapidus Disposable Kit Right, distributed in 16 states. The recall was initiated on 26 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 168B29619B UDI: 00817701020875

Quantity recalled123 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-1501-2021
FDA event ID: 87665
Recalling firm: Nextremity Solutions, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 26 Mar 2021
FDA classified: 27 Apr 2021
Reported: 5 May 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Mar 2021	Recall initiated by company
27 Apr 2021	Classified by FDA	+32 days
5 May 2021	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 could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended

Product as listed by the FDA

InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.

Where it was distributed

AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA

Alaska Alabama California Iowa Illinois Indiana Kentucky Maryland Michigan New Jersey New York Oregon Pennsylvania South Carolina Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number: 168B29619B UDI: 00817701020875

Where was it sold?

AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA

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

1 other product · FDA event 87665

This product is part of a recall event; the main page for the event is InCore Lapidus Disposable Kit Left recalled by Nextremity Solutions.

Reported	Class	Recall	Company	Reason	Where
5 May 2021	CLASS II	InCore Lapidus Disposable Kit Left recalled by Nextremity Solutions	Nextremity Solutions	Other	16 states

Reported	Class	Recall	Company	Reason	Where
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System 4.5 Middle recalled	Nextremity Solutions	Other	Nationwide
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit recalled	Nextremity Solutions	Other	Nationwide
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit recalled	Nextremity Solutions	Other	Nationwide
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System Driver recalled	Nextremity Solutions	Other	Nationwide
20 Apr 2022Device	CLASS II	Nextra Hammertoe Correction System 3.5 Middle recalled	Nextremity Solutions	Other	Nationwide

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