Howmedica Recalls HydroSet XT Injectable HA Bone Cement Due to Expiry Error
Howmedica Osteonics Corp. is recalling HydroSet XT Injectable HA Bone Cement because the product labels display an incorrect expiry date.
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 and involves a minor labeling error regarding the expiry date, which fits the criteria for a moderate severity score.
Plain-English summary
Howmedica Osteonics Corp. is recalling HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE. The recall is due to a labeling error where the product displays an incorrect expiry date of 17-Dec-19, while the correct expiry date is 11-Aug-19.
The affected product is distributed in Colorado, Florida, Georgia, Iowa, Massachusetts, Maine, Michigan, Minnesota, North Carolina, North Dakota, New Hampshire, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin, and West Virginia. The specific lot numbers involved are IC02565 and ICO2570.
Healthcare providers and consumers should stop using the affected product and contact Howmedica Osteonics Corp. for further instructions or a return.
The recalled product
- Product
- HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device — Bone Cement
- Hazard
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 (2)
- UDI - (01)07613327064261 Lot Numbers: IC02565
- ICO2570
Distribution
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. 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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