Stryker Cortoss Bone Augmentation Material Recalled for Temperature Storage Violation
Stryker Spine recalled Cortoss Bone Augmentation Material due to a 12-hour temperature excursion at the distribution center that could have compromised product sterility and efficacy.
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 medical device recall involving a potential risk of harm due to temperature-induced sterility compromise or product degradation. No illnesses or injuries have been reported, keeping the hazard theoretical per the rubric criterion.
Plain-English summary
Stryker Spine has recalled Cortoss Bone Augmentation Material 10cc Cartridge (Catalog Number 2101-0010) due to a 12-hour temperature excursion at the distribution center. The product is designed to be stored under refrigerated conditions, and the temperature violation could have compromised the sterility and function of the material.
The recall affects 559 units distributed nationwide in the United States. The affected lot numbers are A1903054 and A1906006.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
- 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 (2)
- lots A1903054
- A1906006
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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