Reported Nov 11, 2015 · Terminated
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100.…
Stryker Spine
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611
Is this the product you have?
- Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
- Lot codes and dates
Reference Number 48590100 Lots B40155B34446B34447 and B41171
- Amount recalled
- 41 units
Where it was sold
- Nationwide
Why it was recalled
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
This product could cause temporary or reversible health problems — stop using it.
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