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Recall Observatory FDA recall evidence

Device product

Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

Z-2160-2019

June 18, 2019

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 83345
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-2160-2019

Official wording

Reason: 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.

Code information: Lot # B88751 UDI: (01)07613327351576(11)190125(10)B88751

Distribution pattern: US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.