Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, RE
FDA device recall Z-1796-2009 · posted 2009-07-24 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
- Action taken
- Medtronic Sofamor Danek USA, Inc. instructed Sales Representative on starting February 6, 2009 by phone to immediately return product from the field. The firm further issued a "Subject: Medtronic Intrepid Intervertebral Body Fusion Device Recall" notice dated April 2009. The recall notices were mailed directly to Risk Managers and Surgeons, with Recall Questionnaires and Surgeon Confirmation forms included respectively. For further questions, contact your Medtronic Sales Representative or the Medtronic Global Quality Department at 1-800-876-3133 extension 6333.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 637 units
- Distribution
- Worldwide Distribution -- United States, Australia, Germany, The Netherlands, and South Africa.
- Date initiated
- 2009-02-06
- Date posted
- 2009-07-24
- Date terminated
- 2010-04-19
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTREPID SPINAL SYSTEM (K080083) | Medtronic Sofamor Danek | 2008-04-10 |