FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
- Recall number
- Z-2160-2019
- 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
- Status
- Terminated
- Initiated
- 2019-06-18
- Posted
- not on file
- Terminated
- 2020-05-22
- 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.
- 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 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
- Quantity
- 11
- Distribution
- US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
- Lot, serial or model codes
- Lot # B88751 UDI: (01)07613327351576(11)190125(10)B88751
- 510(k) numbers
- ["K170496"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28