Cortoss Bone Augmentation Material Recalled Due to Storage Temperature Excursion
Stryker Spine is recalling 559 units of Cortoss Bone Augmentation Material 5cc Cartridges due to a 12-hour temperature excursion at the distribution center. The affected lot may not meet required storage conditions.
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 3/5 (High).
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: This is an FDA Class II recall involving a medical device with potential for patient harm due to improper storage conditions, but no illnesses or injuries have been reported. Temperature excursion of surgical material falls within the risk-of-harm category without documented injury.
Plain-English summary
Stryker Spine is recalling 559 units of Cortoss Bone Augmentation Material 5cc Cartridges (Catalog Number 2101-0005, lot A1908003). The products experienced a 12-hour excursion from required refrigerated storage temperatures at a distribution center before shipment.
This is a Class II recall issued by the FDA. The affected products were distributed nationwide in the United States.
Healthcare providers and pharmacies with unopened cartridges from lot A1908003 should contact Stryker Spine for instructions. Patients who have already received treatment with material from this lot should contact their healthcare provider with any questions or concerns about their procedure.
The recalled product
- Product
- Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
- Manufacturer
- Stryker Spine
- Affected units
- 559
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)
- lot A1908003
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Stryker Spine 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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