—#174853

Product

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

FDA product code: NKB — Thoracolumbosacral Pedicle Screw System
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K170496
Affected lot / code info: Lot # B88751 UDI: (01)07613327351576(11)190125(10)B88751

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 2 Pearl Ct, Allendale, New Jersey 07401-1611

Distribution

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

Timeline

Recall initiated: 2019-06-18
Terminated: 2020-05-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174853. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.