Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue
Zimmer Biomet is recalling specific hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
What this means for you
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific LPS hip and knee implant components, including precoat and porous femoral heads. The recall involves specific model numbers and sizes distributed worldwide, including the United States and numerous international markets.
The recall is issued because the LDPE bag packaging for these highly polished implants may adhere to the surface. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging.
These devices are indicated for patients with severe knee pain and disability. Healthcare providers and patients should be aware of this potential packaging issue. The source text does not specify specific actions for consumers or report any illnesses or injuries associated with this defect.
The recalled product
- Product
- LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated for patients with severe knee pain and disability
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 48 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.
See all 48 products in this recall →Related recalls
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Same hazard · packaging residue
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- ModerateZimmer Biomet Recalls Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21