Recall Z-1086-2014— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2013-12-18, terminated 2014-08-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Specialty Straight Static Inserter Assembly Product Usage: This 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.. Reason: Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-18
- Terminated
- 2014-08-25
- Firm location
- Allendale, NJ, United States
Product description
Specialty Straight Static Inserter Assembly Product Usage: This 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.
Reason for recall
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Data sourced from openFDA. This site is unofficial and independent of the FDA.