FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Closed knot pusher REF 902813, Biomet Sports Medicine, Warsaw, IN. The device is intended to push knots down a limb of suture.
- Recall number
- Z-0059-2011
- Recalling firm
- Biomet, Inc.
- Product
- Closed knot pusher REF 902813, Biomet Sports Medicine, Warsaw, IN. The device is intended to push knots down a limb of suture.
- Status
- Terminated
- Initiated
- 2010-08-02
- Posted
- 2010-10-14
- Terminated
- 2012-08-20
- Reason
- 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
- Device Design
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- 098750, 278290, 538080, 666270, 864100 and 948870.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXO
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28