FDA Medical Device Recalls (openFDA)
Stryker Spine: Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
- Recall number
- Z-0222-2016
- Recalling firm
- Stryker Spine
- Product
- Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
- Status
- Terminated
- Initiated
- 2015-09-08
- Posted
- 2015-11-05
- Terminated
- 2019-01-14
- Reason
- The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
- Root cause
- Process control
- Action
- Stryker Spine issued an "Urgent Product Removal Notifications /Customer Response Forms dated September 11, 2015. to all affected customers via Fed Ex priority overnight. The notification instructed customers on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Customers were asked to examine their inventory and related hospital location inventories; and reconcile any UniVise Inserters with Catalog numbers and Lot numbers (referenced in the notification). Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance (at 855-632-9049) or email it to Spine-RegulatoryActions@Stryker.com within 5 days of receipt of the notification. For further questions please call (201) 760-8346.
- Quantity
- 41 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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