U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part
FDA device recall Z-0740-2012 · posted 2012-01-13 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- Tip of hex-head screwdriver may break off during use in hip replacement procedure.
- Action taken
- Ortho Development Corporation sent an "URGENT!! DEVICE RECALL" letter dated December 19, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check to see if they have the affected device. Customers who have the device are to return the device to the firm, immediately. The firm will provide suitable replacements. Contact the Regulatory Affairs Manager for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 37 units
- Distribution
- Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT.
- Date initiated
- 2011-12-19
- Date posted
- 2012-01-13
- Date terminated
- 2012-08-27
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESCALADE ACETABULAR CUP SYSTEM (K103384) | Ortho Development | 2011-03-16 |