Recall Z-1612-2009
Stryker Spine · initiated April 30, 2009
Product
Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS, Cestas France. Distributed by Stryker Spine, Allendale, NJ 07401-1677. The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.
Codes / lots: Catalog Number: 48284051, all lots. Mantis Rod inserter Shafts supplied separately, Catalog Number: 48284051.
Reason for recall
The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.
FDA-determined cause: Device Design
Action taken
Stryker Spine issued an "Urgent Product Recall" notification dated April 29, 2009 via Federal Express to all Consignees. Users were instructed to quarantine all affected product and fax a copy of the Product Accountability Form to 201-760-8406. A Stryker sales representative will retrieve the quarantined product. For further information, contact Stryker Spine at 201-760-8206.
Details
- Recall number
- Z-1612-2009
- Initiated
- April 30, 2009
- Posted by FDA
- July 7, 2009
- Terminated
- January 23, 2013
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Quantity
- 387 in US
- Distribution
- Nationwide Distribution.
- Recalling firm
- Stryker Spine, Allendale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1611-2009 | Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas…The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when… | 04/30/2009Terminated |