Z-0175-2012

Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas...

Name: Z-0175-2012 Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas...
Creator: Stryker Spine
Published: 2011-06-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-06-24 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2... on 2011-06-24. The reason FDA records is "There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0175-2012
Status: Terminated
Initiated: 2011-06-24
Posted: 2011-11-08
Terminated: 2012-11-13
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA Stryker Mantis Rod Inserter Inner Shaft Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA IS2097MAN Mantis Rod Inserter Shaft Used to facilitate insertion and delivery of a Mantis rod.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker notified branches/agencies, surgeons and hospitals beginning June 24, 2011 with an Urgent Product Recall letter, dated June 24, 2011, via Fed Ex. The letter identified the affected product, the issue, potential hazards, risk mitigations, and the return process. Customers were asked to examine their inventory and reconcile any inserters and shafts with the catalog numbers provided using the Customer Response Form. Customers are to fax the form to Regulatory Compliance at 201-760-8370 within 5 days of receipt of the letter. The affected product should be retrieved and returned. Questions should be directed to 201-760-8298.
Quantity in commerce: 471 units US, 667 units international
Distribution: Nationwide Distribution
Product codes and lots: All lots

Product code HSB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)