Ortho Solutions Recalls Mislabeled 35mm Non-Locking Orthopedic Screws
Ortho Solutions Inc is recalling 15 units of FPS 35mm x 3.5 mm non-locking screws due to mislabeling of a locking screw batch.
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 and involves a labeling error without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Ortho Solutions Inc is recalling 15 units of FPS 35mm x 3.5 mm non-locking screws. The recall is due to the mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screws as Non-Locking Screws.
The affected product is identified by Part number OS326835 and Lot number 10100/269A12-68051. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should stop using the affected screws and contact Ortho Solutions Inc for further instructions.
The recalled product
- Product
- FPS 35mm x 3.5 mm non-locking screw
- Manufacturer
- Ortho Solutions Inc
- Hazard
- Affected units
- 15
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 number - OS326835 Lot number: 10100/269A12-68051
Distribution
Distribution scope not specified by the agency.
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