Stelkast Recalls Distal Femoral Augments Due to Sterility Breach
Stelkast Co is recalling 11 units of SC2316 Distal Femoral Augments with Screws due to a breach of sterility in the packaging.
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: The recall involves a breach of sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stelkast Co is recalling 11 units of SC2316 Distal Femoral Augments with Screws. These medical devices are used for total knee replacement procedures to treat conditions such as osteoarthritis, osteonecrosis, rheumatoid arthritis, and post-traumatic degenerative problems.
The recall was initiated after the firm became aware of an incident involving a breach of sterility in the sterility barrier packaging of the devices. The affected units are identified by part numbers SC2316-3-5, SC2316-4-5, and SC2316-5-5, with specific lot numbers 22389-111609, 22587-111609, and 23214-111609 respectively.
The products were distributed nationwide, including in Texas, Virginia, Oklahoma, and Pennsylvania. The source text does not specify further actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
- Manufacturer
- Stelkast Co
- Affected units
- 11
Distribution
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