Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Fi
FDA device recall Z-3162-2011 · posted 2011-09-07 · Terminated
Recall details
- Recalling firm
- Orthofix, Inc.
- Reason for recall
- Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.
- Action taken
- Orthofix, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove the affected product from use. Customers were advised to use the combination of the Ratching R Handle and the Set Screw Driver if they experience problems with the Ratching Torque Limiting Handle. A Tracking and Verification form was attached for customers to complete and return to the Orthofix Inc. Regulatory Affairs Department via fax at 214-937-3322. Contact your Account Services Representative at 888-298-5700 for questions regarding the removal and return of the affected product.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 287 units
- Distribution
- Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia and Germany.
- Date initiated
- 2011-04-01
- Date posted
- 2011-09-07
- Date terminated
- 2012-03-23
- Location
- Lewisville, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIREBIRD SPINAL FIXATION SYSTEM (K092624) | Blackstone Medical, Inc. | 2009-09-25 |