Synthes Titanium Trochanteric Fixation Nail Recall for Non-Conforming Blades
Synthes USA is recalling Titanium Trochanteric Fixation Nail (TFN) Helical Blades due to a potential for non-conforming products to be distributed.
What this means for you
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. The source text describes a 'potential' for non-conforming products without reporting any specific injuries, illnesses, or structural failures, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes USA HQ, Inc. is recalling Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades. The recall is issued because a potential exists for non-conforming products to be distributed.
The affected products are used to treat stable and unstable fractures of the proximal femur, including pertrochanteric, intertrochanteric, and basal neck fractures. The specific parts involved are part numbers 456.300-456.310 and 456.650, as well as 456.300S-456.310S and 456.650S, with lot numbers ranging from 5615864 through 7423581.
The recall covers approximately 350,195 units. Distribution was worldwide, including the United States (nationwide), Mexico, and Canada. The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with the recall.
The recalled product
- Product
- Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fra
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 350,195
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 (3)
- part nos. 456.300-456.310 & 456.650
- 456.300S-456.310S & 456.650S
- with lot nos. 5615864 through 7423581
Distribution
Distributed nationwide across the United States.
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