Blue Belt Technologies Recalls Mislabeled Stride Unicondylar Knee Prosthesis Components
Blue Belt Technologies is recalling specific lots of Stride unicondylar knee prosthesis femoral components due to packaging mislabeling that may result in the wrong implant being used.
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, which typically involves situations where use may cause temporary or medically reversible health consequences. The hazard is a labeling error that could lead to the use of the wrong implant, but no injuries or illnesses are reported in the source text.
Plain-English summary
Blue Belt Technologies is recalling two units of Stride Femoral Component Size 2, PFSI-00053, Right Lateral/Left Medial unicondylar knee prosthesis. The recall is due to a mislabeling error where packages labeled PFSI-00053, Right Lateral/Left Medial actually contain PFSI-00054, Right Medial/Left Lateral implants. Conversely, packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral implants.
The affected product is identified by Lot C785231 with an expiration date of 5-2015. The distribution pattern for these units was nationwide in the United States, specifically in the states of California, Pennsylvania, and Texas.
Healthcare providers and facilities should verify the contents of their inventory against the lot and expiration dates provided. If the affected components are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations to prevent the use of incorrect implant components during surgical procedures.
The recalled product
- Product
- Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
- Manufacturer
- Blue Belt Technologies MN
- Hazard
- Affected units
- 2
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)
- Lot C785231
- Exp 5-2015
Distribution
Part of a larger recall action
This product is one of 2 recalled by Blue Belt Technologies MN 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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