OrthoPediatrics Recalls 3.5mm Locking Screws Due to Packaging Labeling Error
OrthoPediatrics Corp is recalling 3.5mm locking screws because the packaging description incorrectly identified them as 7.0mm screws, despite the correct part number.
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 the hazard is a labeling error (mislabeling) rather than a structural defect or contamination. No injuries or illnesses have been reported, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
OrthoPediatrics Corp is recalling 3.5mm locking screws, T15 hexalobe, self-tapping, 34mm, from the OrthoPediatrics Proximal Femur Plating System. The recall involves 7 units shipped worldwide, including the United States (specifically Michigan), Ireland, and Australia. The affected units are identified by Part Number 00-0903-2634 and Lot Number 009U2.
The recall was initiated after the firm received complaints that the packaging material for the 3.5mm screws was marked with the correct part number but contained a description indicating a 7.0mm screw. An internal investigation confirmed that Lot Number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
Healthcare providers and facilities that have received these specific screws should stop using them and contact OrthoPediatrics Corp for instructions on return or replacement. The mislabeling presents a risk of using the incorrect implant size during surgical procedures.
The recalled product
- Product
- 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates…
- Manufacturer
- OrthoPediatrics Corp
- Hazard
- Affected units
- 7
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:. 00-0903-2634 and lot number 009U2
Distribution
Distributed in 1 state:
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