Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
FDA Recall Z-2160-2019 · Posted None
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Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeNKB
Date Initiated2019-06-18
Date Terminated2020-05-22
Product Quantity11
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.
Firm 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 [email protected] 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: [email protected] or 201.749.8090
Root Cause
Labeling mix-ups
Distribution Pattern
US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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