Comprehensive Reverse Shoulder Screws

• • Terminated Z-1131-2021 FDA Class II ·initiated 15 Jan 2021

  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.

• • Terminated Z-0619-2021 FDA Class II ·initiated 25 Nov 2020 ·on shared 510(k) K132239

  Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K132239 ↗

FDA Product Code

PHX

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomet Manufacturing Corp →