Recall Z-1612-2009 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
Stryker Spine
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
| Date | Jul 7, 2009 (initiated Apr 30, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 387 in US |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061813 | MANTIS SPINAL SYSTEM Stryker Spine, Sep 19, 2006 |