| Event ID |
63157 |
|---|
| Product Type |
Devices |
|---|
| Status |
Ongoing |
|---|
| Recalling Firm |
Medtronic Sofamor Danek USA Inc |
|---|
| City |
Memphis |
|---|
| State |
TN |
|---|
| Country |
US |
|---|
| Voluntary/Mandated |
Voluntary: Firm Initiated |
|---|
| Recall Initiation Date |
2012-08-30 |
|---|
| Initial Firm Notification of Consignee or Public |
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
|---|
| Distribution Pattern |
Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico. |
|---|
| Product Description |
Code Info |
Classification |
Reason for Recall |
Product Quantity |
Recall Number |
| ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for
single use, this instrument may be re-used. |
All lots except those starting with SY |
Class II |
Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. |
1047 units |
Z-0036-2013 |
| ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for
single use, this instrument may be re-used. |
All lots except those starting with SY |
Class II |
Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. |
1014 units |
Z-0037-2013 |
| PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for
single use, this instrument may be re-used. |
All lots except those starting with SY |
Class II |
Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. |
247 units |
Z-0038-2013 |
