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

FDA device recall Z-0175-2012 · posted 2011-11-08 · Terminated

Recall details

Recalling firm

Stryker Spine

Reason for recall

There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter.

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.

Root cause

Device Design

Status

Terminated

Product code

HSB

Quantity affected

471 units US, 667 units international

Distribution

Nationwide Distribution

Date initiated

2011-06-24

Date posted

2011-11-08

Date terminated

2012-11-13

Location

Allendale, NJ