OrthoPediatrics ACL Sleeve Installation Tool Recall for Incorrect Size Etching
OrthoPediatrics Corp is recalling 40 ACL Sleeve Installation Tools that may be etched with the wrong size. The tools were shipped in November 2013.
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. The hazard involves a labeling/etching error (wrong size) on a surgical tool, which is a moderate risk of harm but does not meet the criteria for severe injury or death.
Plain-English summary
OrthoPediatrics Corp is recalling 40 units of the ACL Sleeve Installation/Insertion Tool, Part # 01-0108-0040/0047. These tools are part of the OrthoPediatrics ACL Reconstruction System, which is used for pediatric and small stature adult ACL reconstruction surgery.
The recall was initiated because the tools may be etched with the wrong size. The affected units were shipped between November 4, 2013, and November 6, 2013. The distribution was nationwide, including the states of California, Kentucky, Ohio, Rhode Island, and Tennessee.
The specific lot numbers affected are 132762, F132763, F132764, F132765, F132766, F132768, F132769, and F132770. Healthcare providers and consumers should check their inventory for these specific part and lot numbers. If the tools are found, they should be removed from use and returned to OrthoPediatrics Corp.
The recalled product
- Product
- OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated…
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 40
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 (8)
- Part 01-1008-0040/0047 Lot 132762
- F132763
- F132764
- F132765
- F132766
- F132768
- F132769
- F132770
Distribution
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