Recall Z-1086-2014
Stryker Spine · initiated December 18, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242
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.
FDA-determined cause: Device Design
Action taken
Stryker sent Urgent Medical Device Removal Notification letter and to their customers via email on 12/18/2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory, return affected product using enclosed pre-paid mailing label, complete Customer Response Form and fax to Regulatory Compliance at 855-632-9049 or mail it to Spine-RegulatoryActions@Stryker.com. For questions call 201-760-8287, 201-760-8298 or 201-760-8041.
Details
- Recall number
- Z-1086-2014
- Initiated
- December 18, 2013
- Posted by FDA
- February 25, 2014
- Terminated
- August 25, 2014
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 21 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Stryker Spine, Allendale, NJ