Z-0222-2016Class II

Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number...

Name: Z-0222-2016 Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number...
Creator: Stryker Spine
Published: 2015-09-08
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-09-08 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument on 2015-09-08. FDA classified it as Class II and gives the reason as "The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0222-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-08
Posted: 2015-11-05
Terminated: 2019-01-14
Recalling firm: Howmedica Osteonics Corp
Product: Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
Root cause tag: manufacturing process
FDA 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 [email protected] within 5 days of receipt of the notification. For further questions please call (201) 760-8346.
Quantity in commerce: 41 units
Distribution: Nationwide Distribution.
Product codes and lots: Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0222-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0222-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-05

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)