Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It
FDA device recall Z-1086-2014 · posted 2014-02-25 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 21 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2013-12-18
- Date posted
- 2014-02-25
- Date terminated
- 2014-08-25
- Location
- Allendale, NJ
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