Recall Z-2014-2020 ยท HWJ Awl
K2M, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 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.
| Date | Apr 24, 2020 (initiated Apr 13, 2020) |
| Status | Terminated |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.