MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm);

FDA device recall Z-1961-2014 · posted 2014-07-01 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current NewPort MIS System Surgical Technique.

Action taken

A customer notification letter was sent on 6/9/14 to their customers and distributors who purchased the Integra NewPort System MIS Rod, 2 to inform them there may be a potential that the hex on some NewPort System MIS Rod, 2 are up to 30 degrees offset from specification requirements causing misalignment with the inserter. Customers are instructed to complete and return the customer response form and return by email or fax as indicated on the form. Customers with questions are instructed to contact Customer Service at (866) 942-8698.

Root cause

Under Investigation by firm

Status

Terminated

Product code

NKB

Quantity affected

94 units

Distribution

Worldwide Distribution. US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain.

Date initiated

2014-06-09

Date posted

2014-07-01

Date terminated

2014-11-06

Location

Plainsboro, NJ

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