FDA Medical Device Recalls (openFDA)
K2M, Inc: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 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.
- Recall number
- Z-2016-2020
- Recalling firm
- K2M, Inc
- Product
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 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.
- Status
- Terminated
- Initiated
- 2020-04-13
- Posted
- 2020-04-24
- Terminated
- 2021-11-15
- Reason
- 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
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- Lot # FKXE
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWJ
- Firm FEI
- 3008599177
- Firm city
- Leesburg
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28