Reported Mar 5, 2014 · Terminated
Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand .…
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?
- Specialty Straight
- Static Inserter Assembly Product UsageThis instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges
- Lot codes and dates
- D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242
- Amount recalled
- 21 units
Where it was sold
- Nationwide
Why it was recalled
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
This product could cause temporary or reversible health problems — stop using it.
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