Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; D
FDA device recall Z-0790-2010 · posted 2010-02-16 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.
- Action taken
- Stryker Spine issued an "Urgent Product Recall" notification dated January 15, 2010 via Federal Express to all consignees. The letter informed users of the issue and potential hazards of the affected product. For further information, contact your local Stryker Spine Sales Representative or call 201-760-8206.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 2727 total, all sizes
- Distribution
- Nationwide distribution.
- Date initiated
- 2010-01-18
- Date posted
- 2010-02-16
- Date terminated
- 2012-09-06
- Location
- Allendale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.