Zimmer Biomet Recalls Knee Prostheses Due to Packaging Residue
Zimmer Biomet is recalling specific knee prostheses because the packaging bags may leave residue on the implant surface.
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, but the source text describes a packaging defect (residue) without reporting any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of CR POR FEM HATCP Knee Prostheses (Sizes E/L and F/L). The recall involves specific item and lot numbers, including Item 65-5972-015-01 (Lot 62086845) and Item 65-5972-016-01 (Lots 11007043 and 62105229). The affected products were distributed worldwide, including the United States and numerous international markets.
The recall is due to a defect in the LDPE bag packaging used for these highly polished implants. The packaging may adhere to the polished surface, leaving residue or material from the bag on the implant after it is removed. This issue affects the integrity of the implant surface prior to surgical use.
Healthcare providers and facilities that have received these specific lots should stop using the affected prostheses and contact Zimmer Biomet for instructions on return or replacement. Consumers who have had these specific implants placed should consult their healthcare provider regarding the recall.
The recalled product
- Product
- CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis
- 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.
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