Recall Z-1611-2009

Stryker Spine · initiated April 30, 2009

Terminated

Product

Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp; 325 Corporate Drive, Mahwah, NJ 07430. 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 48284050; all lots. The Mantis Rod Inserter Assemblies are distributed packaged with a Mantis Rod Inserter Shaft. Rod Inserter Shalfts supplies with the Mantis Fod Inserter Assembly, Catalog Number: 48284050.

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-1611-2009
Initiated
April 30, 2009
Posted by FDA
July 7, 2009
Terminated
January 23, 2013
Product code
MNH – Orthosis, Spondylolisthesis Spinal Fixation
Quantity
175 in US
Distribution
Nationwide Distribution.
Recalling firm
Stryker Spine, Allendale, NJ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1612-2009 Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS…The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when… 04/30/2009Terminated