Howmedica Recalls HydroSet XT Injectable HA Bone Cement Due to Incorrect Expiry Date
Howmedica Osteonics Corp. is recalling HydroSet XT Injectable HA Bone Cement because the product displays an incorrect expiry date of 9-Feb-20 instead of the correct 30-Aug-19.
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 identifies the issue as a minor labeling error (incorrect expiry date) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Howmedica Osteonics Corp. is recalling HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE, due to a labeling error. The product displays an incorrect expiry date of 9-Feb-20, while the correct expiry date is 30-Aug-19.
The affected product is identified by UDI (01) 07613327064278 and Lot Number IC02595. The recall covers distribution in the following states: CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI, and WV.
Healthcare providers and facilities should check their inventory for this specific lot number and UDI. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- HydroSet XT Injectable HA Bone Cement, REF 897005, 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 (1)
- UDI - (01) 07613327064278 Lot Number: IC02595
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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