Synthes Flexible Shaft Orthopedic Surgical Instrument Recalled for Non-Conforming Material
Synthes (USA) Products LLC is recalling 198 units of Flexible Shaft orthopedic surgical instruments because non-conforming material was used in their manufacture.
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 involves a situation where use of the product could cause temporary or medically reversible health consequences. The source text cites 'non-conforming material' without reporting specific injuries or illnesses, aligning with a moderate severity assessment for a medical device.
Plain-English summary
Synthes (USA) Products LLC is recalling 198 units of Synthes Flexible Shaft, an orthopedic manual surgical instrument. These flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems. The recall is being conducted because non-conforming material was used in the production of the devices.
The affected products were distributed nationwide in the United States. The recall covers specific part numbers and lot numbers, including Part Number 352.040 (Lot # 9947895, L084498) and Part Number 352.044 (Lot # 9916503, 9916508, L000158, L000160, L000573, L000603, L000604, L000605, L000607, L000632, L082974).
Healthcare providers and facilities should check their inventory for these specific part and lot numbers. If the recalled products are found, they should be removed from use and returned to the manufacturer or the appropriate FDA representative as directed.
The recalled product
- Product
- Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 198
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 (10)
- Part Number 352.040 - Lot # 9947895
- L084498 Part Number 352.044 - Lot # 9916503 9916508
- L000158
- L000160
- L000573
- L000603
- L000604
- L000605
- L000607
- L000632 L082974
Distribution
Distributed nationwide across the United States.
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