Z-2019-2020Class II

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog...

Name: Z-2019-2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog...
Creator: K2M, Inc
Published: 2020-04-13
License: https://open.fda.gov/license/

K2M, Inc / initiated 2020-04-13 / Terminated / root cause: design

FDA source

K2M, Inc began a recall of K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm... on 2020-04-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2019-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-13
Posted: 2020-04-24
Terminated: 2021-11-15
Recalling firm: K2M, Inc
Product: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 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.
Product code: HWJ Awl
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.
Root cause tag: design
FDA root cause: Device Design
Action: On April 13, 2020, a Product Recall Notification letter was sent to all affected customers (Distributors and Branches/Agencies). The firm instructed customers to review the notification and then, inform all sales representatives and operation teams within the Branch/Agency. Next, the customers were told to check their inventory to locate the product listed and complete the Business Reply Form, even if no affected products were identified. If product was found on hand, the customers were instructed to indicate the quantity of units on the form and to return the product to the firm.
Distribution: 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.
Product codes and lots: Lot # FKXH

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2019-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2008-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2009-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2010-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2011-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2012-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2013-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2014-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2015-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2016-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2017-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2018-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2019-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2020-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2021-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2022-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2023-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2024-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2025-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2026-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2027-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2028-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2029-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2030-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15
Z-2031-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15

Product code HWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)