Closed knot pusher REF 902813, Biomet Sports Medicine, Warsaw, IN. The device is intended to push knots down a limb of s

FDA device recall Z-0059-2011 · posted 2010-10-14 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

The firm has received four complaints that the closed knot pusher is missing a radius which contributes to sutures being cut during surgery.

Action taken

Biomet Sports Medicine sent URGENT MEDICAL DEVICE RECALL NOTICES dated 8/2/2010 to its customers and distributors. The notices stated that the use of the device should be discontinued and the products returned to Biomet. Healthcare professionals and consumers were to report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/MedWatch/report.htm, by regular mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or by phone at (800)FDA-1088 or Fax (800)FDA-0178. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.

Root cause

Device Design

Status

Terminated

Product code

HXO

Quantity affected

101

Distribution

Worldwide Distribution - USA, including FL, NY, VA, CA, GA, AL, PA, MI, LA, KS, SD, KY, TX, AR, and WV, and the countries of Belgium, Italy, Argentina, Poland, Netherlands, Turkey and Portugal.

Date initiated

2010-08-02

Date posted

2010-10-14

Date terminated

2012-08-20

Location

Warsaw, IN