TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofam
FDA device recall Z-3044-2011 · posted 2011-08-19 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- Screws are 5 mm longer than the size etched on the screw.
- Action taken
- On 07/12/2011, the recalling firm, Medtronic notified the Sales Managers and Sales Force by conference call and email regarding the imminent notification and follow-up activities. A "VOLUNTARY RECALL" notification letter was sent to Risk Managers and Sales Representatives on 07/13/2011 with a delivery date of 07/14/2011. The letter states to immediately remove the recalled product from use and return to Medtronic. The letter includes a questionnaires form to be completed and returned as per the instructions. If appropriate, personal follow up with Sales Representatives will be made to assure that Risk Managers understand the recall communication and to facilitate return of product and the associated questionnaire documentation. For questions, contact your Medtronic Sales Representative or the Global Quality Department at 800-876-3133, extension 3173.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 17 units
- Distribution
- Nationwide Distribution (USA) including the states of: OH, NY, and WI
- Date initiated
- 2011-07-12
- Date posted
- 2011-08-19
- Date terminated
- 2012-07-20
- 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 OF TSRH SPINAL SYSTEM (K984522) | Danek Medical, Inc. | 1999-01-06 |