FDA Medical Device Recalls (openFDA)
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 number
- Z-1611-2009
- Recalling firm
- Stryker Spine
- 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.
- Status
- Terminated
- Initiated
- 2009-04-30
- Posted
- 2009-07-07
- Terminated
- 2013-01-23
- 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
- 175 in US
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K061813"]
- PMA numbers
- not on file
- Product code
- MNH
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28