Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling two lots of Comprehensive Humeral stems used in shoulder replacement surgeries. During manufacturing, the lots were mixed together and labeled with incorrect lot numbers. The two stem sizes differ by 1.1 inches, and the mislabeling is visually apparent—the box label does not match what is actually inside. The recalled products were distributed nationwide in Minnesota, New Jersey, California, Texas, and North Dakota, with 12 units affected.
The specific recalled product is the Humeral Stem 83mm (Size 17), identified by part number 113633 and lot number 421700. The source document does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
Reason for recall: Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box. Distribution: US Nationwide in the states of MN, NJ, CA, TX, ND Quantity: 12 Lot/code info: PN: 113633, LN: 421700, UDI# - (01) 00880304462632 (17) 271014 (10) 421700
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.