OrthoPediatrics Recalls 7.0mm Pedicle Screws Due to Color Anodizing Error
OrthoPediatrics Corp is recalling 24 units of 7.0mm x 40mm pedicle screws because they were color anodized with the same color used for 5mm screws.
What this means for you
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 indicates a temporary or medically reversible adverse health consequence. The hazard is a labeling error (color anodizing) that could lead to the use of the wrong size screw, but no injuries or illnesses are reported in the source text.
Plain-English summary
OrthoPediatrics Corp is recalling 24 units of Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screws. The affected product is identified by Model number 00-1300-0740 and Lot number M82791-1. These screws are intended for posterior non-cervical pedicle screw fixation.
The recall was initiated because the 7mm diameter uniaxial pedicle screws were color anodized with the same color utilized on 5 mm diameter screws. This labeling error could potentially lead to the use of the wrong size screw during surgical procedures.
The affected units were distributed nationwide in the United States. Healthcare providers and patients should check their inventory for the specific model and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority.
The recalled product
- Product
- Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
- Manufacturer
- OrthoPediatrics Corp
- Hazard
- Affected units
- 24
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)
- Model number: 00-1300-0740
- Lot number: M82791-1
Distribution
Distributed nationwide across the United States.
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