Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesi
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is voluntarily recalling 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging failures discovered during testing. During simulated distribution and shipping tests, 9 of 16 samples failed when the hip stem breached either the inner or outer package tray. Although Zimmer has not received any complaints of damaged package trays related to these lots, the company is taking action based on the test results. A total of 68 units were distributed nationwide in Indiana, Wisconsin, Minnesota, Oregon, and Texas, with one unit sent to a consignee in Canada.
The recall affects 20 specific production lots with identified part and lot numbers. The source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lot
Reason for recall: Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lot Distribution: Worldwide Distribution - US (nationwide) in the states of IN, WI, MN, OR, and TX, and one foreign consignee in Canada. Quantity: 68 Lot/code info: Part 00402100838, Lot 62435853; Part 00402100841, Lot 62435854; Part 00402100843, Lot 62396506; Part 00402100844, Lot 62424468; Part 00402100848, Lot 62435852; Part 00402100848, Lot 62467218; Part 00402100848, Lot 62511381; Part 00402100851, 37108214; Part 00402100852, Lot 62511377; Part 00402100854, Lot 62511379; Part 00402101241, Lot 62352570; Part 00402101244, Lot 62424469; Part 00402101246, Lot 62400669; Part 00402101248, Lot 62400670; Part 00402101249, Lot 62467222; Part 00402101251, Lot 62470576; Part 00402101252, Lot 62435851; Part 00402101254, Lot 62424470; Part 00402101257, Lot 62524114; & Part 00402101260, Lot 62524115.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.