Synthes Recalls 3.7mm Cannulated Screws Due to Incorrect Labeling
Synthes, Inc. is recalling 54 units of 3.7mm Cannulated Locking and Conical Screws because certain lots were found to have been labeled incorrectly.
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, but the source text explicitly states the issue is incorrect labeling without reporting any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Synthes, Inc. is recalling 54 units of 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws. The recall involves specific part numbers (02.240.044, 02.240.244) and lot numbers (8886011, 8886046). These medical devices are indicated for the fixation of fractures, osteotomies, and non-unions in various bones, particularly in osteopenic bone.
The recall was initiated because certain lots of these screws were found to have been labeled incorrectly. The source text does not specify the nature of the labeling error or report any associated injuries or illnesses.
The affected products were distributed nationwide. Healthcare providers and facilities should identify and stop using the affected lots. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic…
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 54
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 (4)
- Part Numbers: 02.240.044
- 02.240.244
- Lot Numbers 8886011
- 8886046
Distribution
Distributed nationwide across the United States.
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