Zimmer Recalls Moore Hip Prosthesis Stems Due to Packaging Failures
Zimmer, Inc. is voluntarily recalling 68 units of Moore Hip Prosthesis Long Fenestrated Stems because packaging design verification tests failed, allowing stems to breach package trays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a packaging defect with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is initiating a voluntary recall of 68 units of Moore Hip Prosthesis Long Fenestrated Stems. The recall involves 20 production lots distributed nationwide in Indiana, Wisconsin, Minnesota, Oregon, and Texas, as well as to one foreign consignee in Canada.
The recall was initiated due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lots.
Consumers and healthcare providers should contact Zimmer, Inc. for further information regarding the recall and replacement of affected units.
The recalled product
- 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 stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 68
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part 00402100838
- Lot 62435853
- Part 00402100841
- Lot 62435854
- Part 00402100843
- Lot 62396506
- Part 00402100844
- Lot 62424468
- Part 00402100848
- Lot 62435852
- Lot 62467218
- Lot 62511381
- Part 00402100851
- 37108214
- Part 00402100852
- Lot 62511377
- Part 00402100854
- Lot 62511379
- Part 00402101241
- Lot 62352570
Distribution
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