K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-901

FDA device recall Z-2027-2020 · posted 2020-04-24 · Terminated

Recall details

Recalling firm

K2M, Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

HWJ

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

Date initiated

2020-04-13

Date posted

2020-04-24

Date terminated

2021-11-15

Location

Leesburg, VA