notyard
04-15-2009, 09:06 AM
FDA class II recall:
PRODUCT
a) Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1014-2009;
b) Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; REF 8351510. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1015-2009;
c) Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1016-2009;
d) Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; REF 8351512. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1017-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, Warsaw, IN, by letters dated January 9, 2009.
Manufacturer: Medtronic Sofamor Danek USA Inc., Memphis, TN. Firm initiated recall is ongoing.
REASON
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
VOLUME OF PRODUCT IN COMMERCE
4,110 connectors and 43 sets
DISTRIBUTION
Nationwide
PRODUCT
a) Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1014-2009;
b) Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; REF 8351510. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1015-2009;
c) Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1016-2009;
d) Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; REF 8351512. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1017-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, Warsaw, IN, by letters dated January 9, 2009.
Manufacturer: Medtronic Sofamor Danek USA Inc., Memphis, TN. Firm initiated recall is ongoing.
REASON
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
VOLUME OF PRODUCT IN COMMERCE
4,110 connectors and 43 sets
DISTRIBUTION
Nationwide