CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY,
FDA device recall Z-0465-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- One screw may be longer then size etched on the screw.
- Action taken
- Medtronic Sofamor Danek USA, Inc sent a Voluntary Field Correction letter dated November 30, 2011, via FedEx to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The firm will visit each consignee to perform a visual check of inventory. Please utilize the attached questionnare to account for the affected product and to record any patient injuries that may have occurred specifically related to the use of these items. If you need assistance, or if you have any related questions or concerns please call (800) 876-3133 extension 3173
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 30 units
- Distribution
- Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.
- Date initiated
- 2011-11-30
- Date posted
- 2012-01-11
- Date terminated
- 2012-04-05
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K042025) | Medtronic Sofamor Danek, Inc. | 2004-08-25 |