Stryker Recalls HydroSet Injectable HA Bone Substitute Due to Leaking Desiccant
Stryker is recalling HydroSet Injectable HA Bone Substitute kits because desiccant bags may leak silica gel, posing risks of foreign body reactions or increased anesthesia exposure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (foreign body reaction, inflammation, revision surgery) where the source text does not explicitly state that injuries or illnesses have already been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Craniomaxillofacial Division is recalling specific lots of HydroSet Injectable HA Bone Substitute, a self-setting calcium phosphate cement used for cranial and craniofacial defects. The recall involves 12,719 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated after Stryker received reports that the desiccant bag in the kit was leaking silica gel granulate. This defect could lead to inadvertent implantation of the silica gel, which may cause a foreign body reaction, inflammation, and potentially the need for revision surgery. Additionally, the leak could increase exposure to anesthesia during surgical delay of up to 60 minutes.
Healthcare providers and patients should stop using the affected product immediately. Stryker is working to identify and retrieve the specific lots listed in the recall notice to prevent further use of the defective kits.
The recalled product
- Product
- Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-settin
- Manufacturer
- Stryker Craniomaxillofacial Division
- Affected units
- 12,719
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 (20)
- Part 79-43903
- Lot: IC01116
- IC01130
- IC01204
- IC01233
- IC01238 Part 79-43905 Lot: IC01084
- IC01085
- IC01086
- IC01093
- IC01123
- IC01150
- IC01166
- IC01167
- IC01168
- IC01180
- IC01188
- IC01189
- IC01190
- IC01198
- IC01199
Distribution
Distributed nationwide across the United States.
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