Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. Product Usage: : Reusable instrument
FDA device recall Z-1706-2012 · posted 2012-06-05 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Stryker received four reports regarding a handle which separates at the point where it is welded to the shaft on the Xia 3 Anti-Torque Key during surgery.
- Action taken
- Stryker Spine sent an Urgent Product Recall letter dated January 12, 2012 with an attached Customer Response forms via FEDEX to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory to identify the affected product and return using the prepaid mailing label provided. The letter asked customers to complete the Customer Response Form and fax to 201.760.8370. For questions call 201.760.8298.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 95 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2012-01-12
- Date posted
- 2012-06-05
- Date terminated
- 2013-03-21
- Location
- Allendale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER SPINE XIA III SPINAL SYSTEM (K071373) | Stryker Spine | 2007-08-27 |