Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm diameter x 21
FDA device recall Z-0151-2009 · posted 2008-10-20 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.
- Action taken
- Urgent Product Recall notification letters were sent via Fed Express on August 18, 2008 to Stryker Branches and Hospital Risk Managers. The firm asked customers to examine their inventory and hospital locations to identify the product; reconcile all products on the Product Accountability Form and attached distribution sheet; and fax a copy of the Accountability Form and distribution sheet to Sarah Thompson within 5 days of receipt of the notice. All questions are to be directed to Susan Krasny at 201-760-8150.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 69 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-08-18
- Date posted
- 2008-10-20
- Date terminated
- 2008-11-04
- Location
- Allendale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.