PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 20, 2014 Initiated: July 1, 2014 #Z-2215-2014

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

Details

Recalling Firm
Zimmer, Inc.
Units Affected
68
Distribution
Worldwide Distribution - US (nationwide) in the states of IN, WI, MN, OR, and TX, and one foreign consignee in Canada.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Zimmer, Inc.. Units affected: 68.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2014. Severity: Moderate. Recall number: Z-2215-2014.

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