Z-2160-2019Class II

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

Name: Z-2160-2019 Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog...
Creator: Howmedica Osteonics Corp.
Published: 2019-06-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2019-06-18 / Terminated / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100 on 2019-06-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2160-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-18
Posted: 2019-08-05
Terminated: 2020-05-22
Recalling firm: Howmedica Osteonics Corp
Product: Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: labeling and UDI
FDA root cause: 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 [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
Quantity in commerce: 11
Distribution: US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
Product codes and lots: Lot # B88751 UDI: (01)07613327351576(11)190125(10)B88751

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2160-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2160-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05

Product code NKB

K170496Class IIXia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation / cleared 2017-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)