Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue
Zimmer Biomet is recalling 13,227 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 illnesses, injuries, or hospitalizations. The hazard is a potential contamination issue (residue) without confirmed adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of CR Precoat and CR Porous femoral components for hip and knee implants. The recall is due to a defect in the Low-Density Polyethylene (LDPE) bag packaging used for these devices.
The LDPE bag packaging may adhere to the highly polished surface of the implants. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging. The affected devices are indicated for patients with severe knee pain and disability.
The recall covers specific catalog numbers and lot codes for various sizes of the CR Precoat and CR Porous femoral components. The devices were distributed worldwide, including in the United States and numerous international markets. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these specific units.
The recalled product
- Product
- CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS F
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 13,227
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
See all →- ModerateZimmer Biomet Recalls Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
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FDA (Devices) · 2018-03-21
- 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
- ModerateZimmer Biomet Recalls Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21