Orthohelix Intraosseous Fixation System Drill Bits Recalled for Manufacturing Defect
Orthohelix Surgical Designs Inc is recalling specific lots of Intraosseous Fixation System drill bits because a burr prevents them from fitting over the guide wire.
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 defect is a functional manufacturing issue (burr) that prevents the device from fitting the guide wire, without reported injuries or illnesses.
Plain-English summary
Orthohelix Surgical Designs Inc is recalling specific lots of Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm, and 2.5 mm Cannulated Drill Bits. The affected units are identified by Part numbers IFS-072-17-C, IFS-72-20-C, and IFS-072-25-C, and Lot numbers 2399041, 2399051, 2399051R, and 2399061.
The recall was initiated after a customer notified the firm that a burr on the inside end of the drill bit prevented it from fitting over the associated guide wire. This manufacturing defect affects the intended function of the device, which is to stabilize and aid in the fixation of fractures.
The affected products were distributed nationwide, including in California, Colorado, Illinois, Michigan, Maryland, North Carolina, New Mexico, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Utah, Virginia, Washington, and Wisconsin. Healthcare facilities and distributors should stop using the affected drill bits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
- Manufacturer
- Orthohelix Surgical Designs Inc
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 (5)
- Part #: IFS-072-17-C
- Lot #: 2399041
- Part #: IFS-72-20-C
- Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C
- Lot #: 2399061.
Distribution
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