Stelkast Recalls EXp Tibial Inserts Due to Manufacturing Defect
Stelkast Co is recalling 553 EXp Tibial Inserts because a missing lead-in radius may make it difficult to lock the inserts into tibial trays.
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. The hazard involves a manufacturing defect that may make assembly difficult, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
Stelkast Co is recalling 553 units of the EXp Tibial Insert, part of the Proven Gen-Flex Total Knee System. The recall is due to a manufacturing condition where a lead-in radius on the anterior locking tab is missing on certain lots. This defect may prevent or make the assembly of the insert and tray difficult.
The affected devices are intended for total knee replacement and revision surgeries. The recall covers specific part numbers SC3425 and SC3453 with various lot numbers. Distribution was reported in Texas, Maryland, Indiana, Kansas, California, Pennsylvania, Georgia, Washington, New York, and Illinois.
Consumers and healthcare providers should stop using the affected inserts and contact Stelkast Co for further instructions.
The recalled product
- Product
- EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous…
- Manufacturer
- Stelkast Co
- Affected units
- 553
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)
- part numbers SC3425 and SC3453
Distribution
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