FDA-Device2021-02-24Class II
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Biomet, Inc.
Hazard
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Sold states
US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN.
Affected count
49
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief