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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = NKB
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