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U.S. Department of Health and Human Services

Class 2 Device Recall YUKON Polyaxial Screws

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  Class 2 Device Recall YUKON Polyaxial Screws see related information
Date Initiated by Firm July 24, 2018
Create Date October 09, 2019
Recall Status1 Terminated 3 on October 01, 2020
Recall Number Z-0110-2020
Recall Event ID 83768
510(K)Number K171444  
Product Classification Posterior cervical screw system - Product Code NKG
Product YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA
3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm,
4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm,
4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm)

Catalog Numbers 7601-03512, 7601-03514,
7601-03532, 7601-03534,
7601-03538L, 7601-03540L,
7601-04016L, 7601-04018L,
7601-04020L, 7601-04022L,
7601-04024L, 7601-04026L,
7601-04028L, 7601-04030,
7601-05022, 7601-05028,
7601-05030
Code Information Lots FUVD, FUVE, FUVG, FUWF, FUWK, FUWL, FUWU, FUWV, FUWW, FUXK, FUXL,FUXM, FUXN, FUXP, FUXR, FUXT, FUXU, FUXV
Recalling Firm/
Manufacturer		 K2M, Inc
600 Hope Pkwy SE
Leesburg VA 20175-4428
For Additional Information Contact Customer Contact
201-749-8090
Manufacturer Reason
for Recall		 Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018.
FDA Determined
Cause 2		 Process control
Action K2M notified customers with a Recall Notification Letter dated July 24, 2018. The letter instructed customers to locate and segregate recalled product, complete a tracking/verification form, and return the product to K2M.
Quantity in Commerce 364
Distribution Distributed to accounts in AL, CA, CO, FL, IL, KY, LA, MD, MI, MN, MS, NC, NJ, NY, OH, OK, PA, TN, TX, and WA.. Foreign distribution to Australia.
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.
510(K) Database 510(K)s with Product Code = NKG and Original Applicant = K2M, Inc.
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