Synthes 2.4 and 2.7 mm Locking Screws Recalled for Mislabeling
Synthes USA is recalling 98 units of 2.4 and 2.7 mm Locking Screws because 2.7 mm screws were incorrectly labeled as 2.4 mm.
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 involves a labeling error without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Synthes USA HQ, Inc. is recalling 98 units of 2.4 and 2.7 mm Locking Screws (Lot 3420620) due to a mislabeling issue. The recall involves specific lots of the SS 2.4mm and SS 2.7mm Locking Screws (self-tapping) where the 2.7mm screws were incorrectly labeled as 2.4mm screws.
The affected products are intended for the fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. The recall covers nationwide distribution, including Pennsylvania, California, Florida, Missouri, Kansas, Indiana, Illinois, West Virginia, Kentucky, Louisiana, New Mexico, South Carolina, Iowa, Texas, Arizona, Georgia, North Carolina, Oklahoma, New York, Tennessee, Michigan, Colorado, and Montana.
Healthcare providers and facilities should stop using the affected lots and contact Synthes USA for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 98
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 3420620
Distribution
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