—#94039

Product

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

FDA product code: HXO — Pusher, Socket
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 098750, 278290, 538080, 666270, 864100 and 948870.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-08-02
Posted by FDA: 2010-10-14
Terminated: 2012-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94039. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.