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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 18, 2019
Create Date August 05, 2019
Recall Status1 Terminated 3 on May 22, 2020
Recall Number Z-2160-2019
Recall Event ID 83345
510(K)Number K170496  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product Serrato 9.5mm X 90mm Polyaxial Screw
Catalog Number 482619590
Serrato 9.5mm X 100mm Polyaxial Screw
Catalog Number 4826195100
Code Information Lot # B88751 UDI: (01)07613327351576(11)190125(10)B88751
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact
201-760-8000
Manufacturer Reason
for Recall		 Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.
FDA Determined
Cause 2		 Labeling mix-ups
Action 1. Please note this product has already been removed by your local Stryker Sales Representative and/or Stryker Branch or Agency. This communication is being made for notification purposes only; there are no additional product return requirements for this matter. 2. Please assist us in meeting our regulatory obligation by completing and signing the enclosed Product Recall Acknowledgment Form and email a copy to Stryker Spine at SpineRegulatoryActions@Stryker.com or fax the form to 201-575-4675. If you have any questions, please contact Christa Joisil or Matthew Kelleher from the Regulatory Compliance Team: Spine-RegulatoryActions@Stryker.com or 201.749.8090
Quantity in Commerce 11
Distribution US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
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 = NKB and Original Applicant = Stryker Corporation
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