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.
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 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- HighStryker Triathlon size 3 baseplate packaging contained a size 4 implant
FDA (Devices) · 2026-06-24
- HighStryker Triathlon size 4 baseplate packaging contained a size 3 implant
FDA (Devices) · 2026-06-24
- HighStryker sagittal saw attachment cover screws may loosen and detach
FDA (Devices) · 2026-03-25
- ModerateCranial tracker devices recalled over an error message preventing use
FDA (Devices) · 2025-12-31
- ModerateHip stems recalled over potential mix of two catalog numbers in packaging
FDA (Devices) · 2025-10-08
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02