Reported Aug 20, 2014 · Terminated
Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length
- Product UsageThe 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
- Lot codes and dates
20 of 20 products
Products covered by this recall Model / number Product as published 00402100838Lot 62435853 00402100841Lot 62435854 00402100843Lot 62396506 00402100844Lot 62424468 00402100848Lot 62435852 00402100848Lot 62467218 00402100848Lot 62511381 0040210085137108214 00402100852Lot 62511377 00402100854Lot 62511379 00402101241Lot 62352570 00402101244Lot 62424469 00402101246Lot 62400669 00402101248Lot 62400670 00402101249Lot 62467222 00402101251Lot 62470576 00402101252Lot 62435851 00402101254Lot 62424470 00402101257Lot 62524114 00402101260& , Lot 62524115. - Amount recalled
- 68
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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