Synthes 14.5 mm Outer Protection Sleeve Recalled for Incorrect Size
Synthes (USA) Products LLC is recalling 55 units of 14.5 mm Outer Protection Sleeves that were incorrectly packaged as 12.0 mm units.
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, which typically corresponds to a moderate severity score. The hazard involves a packaging error where the wrong size of a medical device was shipped, which could lead to improper use or injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Synthes (USA) Products LLC is recalling 55 units of the Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar. The product is part of the Synthes Tibial Nail System EX, used to stabilize fractures of the proximal and distal tibia and the tibia shaft, as well as open and closed tibia shaft fractures, certain pre- and post-isthmic fractures, and tibial malunions and non-unions.
The recall was initiated after complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar actually contained a 12.0 mm Outer Protection Sleeve for Suprapatellar. The affected units are identified by part no. 03010.438S and lot 706802.
The recall covers a nationwide distribution of the 55 affected units. Healthcare providers and facilities should check their inventory for this specific part number and lot number. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft…
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 55
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 (2)
- part no. 03010.438S
- lot 706802
Distribution
Distributed nationwide across the United States.
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