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.
- Company
- Stryker Spine
- Recall Initiated
- June 24, 2011
- Posted
- November 8, 2011
- Terminated
- November 13, 2012
- Recall Number
- Z-0175-2012
- Quantity
- 471 units US, 667 units international
- Firm Location
- Allendale, NJ
Reason for Recall
There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter.
Distribution
Nationwide Distribution
Lot / Code Info
All lots
Root Cause
Device Design
Action Taken
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.