| Class 2 Device Recall Mantis Rod Inserter | |
Date Initiated by Firm | June 24, 2011 |
Date Posted | November 08, 2011 |
Recall Status1 |
Terminated 3 on November 13, 2012 |
Recall Number | Z-0175-2012 |
Recall Event ID |
59996 |
Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
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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. |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Stryker Spine 2 Pearl Ct Allendale NJ 07401-1611
|
For Additional Information Contact | Ms. Michelle Barry 201-760-8287 |
Manufacturer Reason for Recall | There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter. |
FDA Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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