Moore Hip Prosthesis Long Fenestrated Stem 38 mm recall
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…
Why was Moore Hip Prosthesis Long Fenestrated Stem 38 mm 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 68
- Distribution
- Worldwide Distribution - US (nationwide) in the states of IN, WI, MN, OR, and TX, and one foreign consignee in Canada.
- Recall date
- August 20, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)