Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 49 units of the Comprehensive Reverse Shoulder Central Screw, 25 MM Length, due to a packaging error discovered through complaint investigation. The recalled lot contains screws that are actually 40 MM in length but were incorrectly packaged and labeled as 25 MM length screws. The affected product is identified as Model No. 115395, Lot No. 077170, and was distributed nationwide to medical facilities in Mississippi, Minnesota, Kentucky, Florida, Michigan, Ohio, Arizona, Illinois, Wisconsin, California, Utah, and Tennessee.
The screws are sterile medical devices used for implantable shoulder prosthesis assembly and fixation. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN. Quantity: 49 Lot/code info: Model No.: 115395, Lot No.: 077170, UDI: (01) 00880304677074 (17) 301010 (10) 077170
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.