CLASS II Device recall · Reported 11 Nov 2015 · FDA Enforcement Report

Stryker UniVise Spinous Process Fixation Plate System recalled

Stryker Spine is recalling Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile, distributed nationwide in the US. The recall was initiated on 8 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference Number 48590100 Lots B40155, B34446, B34447 and B41171.

Quantity recalled41 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0222-2016
FDA event ID: 72495
Recalling firm: Stryker Spine, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 8 Sep 2015
FDA classified: 5 Nov 2015
Reported: 11 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

8 Sep 2015	Recall initiated by company
5 Nov 2015	Classified by FDA	+58 days
11 Nov 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.

Which lots are affected?

Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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