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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Spine

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  Class 2 Device Recall Stryker Spine see related information
Date Initiated by Firm April 13, 2020
Date Posted April 24, 2020
Recall Status1 Terminated 3 on November 15, 2021
Recall Number Z-2015-2020
Recall Event ID 85491
Product Classification Awl - Product Code HWJ
Product K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Size 24x8mm, 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.
Code Information Lot # FKXD
Recalling Firm/
Manufacturer		 K2M, Inc
600 Hope Pkwy SE
Leesburg VA 20175-4428
For Additional Information Contact Ms. Margarita Karan
201-749-8389
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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