Recall Z-3044-2011
Medtronic Sofamor Danek USA Inc · initiated July 12, 2011
Product
TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofamor Danek USA. Product Usage: TSRH(R) Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumber, and/or sacral spine.
Codes / lots: Lot number 0149857W
Reason for recall
Screws are 5 mm longer than the size etched on the screw.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-3044-2011
- Initiated
- July 12, 2011
- Posted by FDA
- August 19, 2011
- Terminated
- July 20, 2012
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 17 units
- Distribution
- Nationwide Distribution (USA) including the states of: OH, NY, and WI
- Recalling firm
- Medtronic Sofamor Danek USA Inc, Memphis, TN