Z-2215-2014 Class II Terminated
FDA device recall Z-2215-2014 was initiated by Zimmer, Inc. on Jul 1, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jan 9, 2015). Affected quantity: 68.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 20, 2014
- Initiation Date
- Jul 1, 2014
- Termination Date
- Jan 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68
Product Description
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 prosthesis with or without bone cement.
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 Pattern
Worldwide Distribution - US (nationwide) in the states of IN, WI, MN, OR, and TX, and one foreign consignee in Canada.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2215-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026