Recall Z-0141-2008
Medtronic Sofamor Danek USA Inc · initiated September 4, 2007
Product
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
Codes / lots: Lot Numbers: CN06M012, CN07A025, 434167, 510185, 511648, 510180, 511650, 510189, 515311, 513692, 521191, 523113, 421195 and 521188
Reason for recall
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0141-2008
- Initiated
- September 4, 2007
- Posted by FDA
- December 19, 2007
- Terminated
- November 3, 2008
- Product code
- MJO – Prosthesis, Intervertebral Disc
- Quantity
- 196 units
- Distribution
- Nationwide
- Recalling firm
- Medtronic Sofamor Danek USA Inc, Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0138-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | 09/04/2007Terminated |
| Z-0139-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | 09/04/2007Terminated |
| Z-0140-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | 09/04/2007Terminated |
| Z-0142-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | 09/04/2007Terminated |
| Z-0143-2008 | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #:…Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be… | 09/04/2007Terminated |