Humeral Stem 55mm(Size 13) 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 12 Comprehensive Humeral Stem 55mm (Size 13) devices used in shoulder replacement surgeries. During manufacturing, two different lots of stems were mixed together and etched with incorrect lot numbers. The stems differ in size by 1.1 inches, and the mismatch between the box label and the actual contents inside can be visually identified by the user. The affected devices were distributed nationwide in Minnesota, New Jersey, California, Texas, and North Dakota.
The recall involves devices with part number 113617, lot number 552850, and specific UDI codes. The source document does not specify a remedy or recommended action for consumers who may have received affected products.
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: 113617, LN: 552850, UDI# - (01) 00880304554184 (17) 271014 (10) 552850
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.