Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog: 6972267, SIZE 7 X 16, MATL: Stainles
FDA device recall Z-0142-2008 · posted 2007-12-19 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be imporperly seated.
- Action taken
- The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MJO
- Quantity affected
- 196 units
- Distribution
- Nationwide
- Date initiated
- 2007-09-04
- Date posted
- 2007-12-19
- Date terminated
- 2008-11-03
- Location
- Memphis, TN
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