Xia 3 System - Serrato recallZ-2160-2019 · Howmedica Osteonics Corp. · initiated Jun 18, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Labeling mix-ups
What the company is doing
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
Recall details
- Recall number
- Z-2160-2019
- Status
- Terminated
- Initiated by the company
- Jun 18, 2019
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 11
- Product code
- NKB
- FDA submissions
- K170496
- Distribution
- US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
Product description
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Code information (models, lots, serial numbers)
Lot # B88751 UDI: (01)07613327351576(11)190125(10)B88751
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Xia 3 System - Serrato 482619590Stryker Corporation · Thoracolumbosacral pedicle screw system1 recall6 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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