Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier betwe

FDA device recall Z-2326-2012 · posted 2012-09-06 · Terminated

Recall details

Recalling firm

Breg Inc, An Orthofix Company

Reason for recall

This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.

Action taken

The firm, Breg Orthofix, called their customers on August 11, 2010 sent a letter dated August 12, 2010 and emails to all customers. The call and letter described the product, problem and actions to be taken. The customers were instructed to take immediate action to identify and quarantine the product at their facility. Breg established a return materials authorization and is contacting their customers to provide a Return Authorization to return the dressings. Breg is also providing replacement dressings. If you have any questions regarding communication or the Intelli-Flo Sterile Dressing, contact Breg Customer Relations at (800) 321-0607.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KGX

Quantity affected

502 units

Distribution

Worldwide distribution: USA (nationwide) and country of: Nova Scotia.

Date initiated

2010-08-11

Date posted

2012-09-06

Date terminated

2012-09-06

Location

Carlsbad, CA