Zimmer Biomet Recalls Gender PFJ Femoral Components Due to Packaging Defect
Zimmer Biomet is recalling 5,103 Gender PFJ Femoral Components because the LDPE packaging bag adheres to the implant surface. The device is distributed worldwide.
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 classified as FDA Class II. The hazard is a packaging defect (bag adhesion) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a potential risk of harm without confirmed adverse events.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,103 units of the Gender PFJ Femoral Component, a semi-constrained, uncemented, porous-coated knee prosthesis. The recall is due to a defect where the LDPE bag containing the implant adheres to the highly polished implant surface.
The affected devices are distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Argentina, Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. The recall covers specific item numbers and a large list of lot numbers.
Consumers and healthcare providers should stop using the affected devices and contact Zimmer Biomet for further instructions. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,103
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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