CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report

Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled

K2M is recalling Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, distributed nationwide in the US. The recall was initiated on 13 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # FKXP

Quantity recalledN/A

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-2025-2020
FDA event ID: 85491
Recalling firm: K2M, Leesburg, VA
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2020
FDA classified: 15 May 2020
Reported: 27 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

13 Apr 2020	Recall initiated by company
15 May 2020	Classified by FDA	+32 days
27 May 2020	Published in enforcement report	+12 days

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

Reason for recall

The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.

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

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 10888857108769, Size 28x4mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, Missouri and the country of Europe.

Nationwide California Colorado Florida Kansas Maryland Michigan Missouri Montana New York Oregon Texas

Questions about this recall

Why was it recalled?

The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.

Which lots are affected?

Lot # FKXP

Where was it sold?

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

23 other products · FDA event 85491

This product is part of a recall event; the main page for the event is Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled.

Reported	Class	Recall	Company	Reason	Where
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide
27 May 2020	CLASS II	Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader recalled	K2M	Device Malfunction	Nationwide

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Other Spinal Implants recalls

All 1,157

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9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
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2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide