OrthoPediatrics Recalls 3.5mm Locking Cortical Bone Screws Due to Packaging Error
OrthoPediatrics is recalling 12 units of 3.5mm Locking Cortical Bone Screws because the packages incorrectly contain non-locking 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, but the hazard is a packaging error (incorrect device in package) rather than a contamination or structural defect, and no injuries or illnesses are reported in the source text.
Plain-English summary
OrthoPediatrics Corp has initiated a voluntary recall of 12 units of 3.5mm Locking Cortical Bone Screws, Part No. 00-0903-2620, Lot 009SV. The recall is necessary because the devices within the packages may be incorrect, specifically containing 3.5mm Non Locking Cortical Screws (Part No. 00-1050-3524) instead of the labeled locking screws.
The affected devices are distributed worldwide, including in the United States (specifically Oklahoma, Kentucky, Florida, Louisiana, Ohio, Colorado, Missouri, and Minnesota) and internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany. These screws are designed for use with OrthoPediatrics Pediloc Tibia Plates, which are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia.
Healthcare providers and patients should stop using the affected screws and contact OrthoPediatrics Corp for further instructions or replacement. The recall is limited to the specific lot and part number identified in the notice.
The recalled product
- Product
- 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 12
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)
- Lot 009SV
Distribution
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