Stryker Spine 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stryker Spine
Lot Codes / Batch Numbers
Catalog Number 48284050, Catalog Number: 48284050.
Products Sold
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.
Stryker Spine is recalling Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas, France. Distri due to The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user fr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026