Recall Z-1086-2014 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
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 de
| Date | Feb 25, 2014 (initiated Dec 18, 2013) |
| Status | Terminated |
| Reason | Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 21 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.