Synthes Trochanteric Fixation Nail Recalled for Incorrect Packaging Labeling
Synthes USA is recalling 12 Trochanteric Fixation Nails because the packaging incorrectly lists the nail's length and diameter.
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 regarding device dimensions. This fits the rubric for moderate severity, as it is a labeling issue that could lead to improper use but does not involve a structural defect or reported injuries.
Plain-English summary
Synthes USA HQ, Inc. is recalling 12 units of the Synthes Trochanteric Fixation Nail (TFN) Nail. This medical device is part of the TFN System and is intended to treat stable and unstable fractures of the proximal femur.
The recall was initiated because certain lots of the nail were distributed with incorrect labeling on the packaging. Specifically, the length and diameter of the nail were mislabeled. The affected products include Part 456.475S, lot # 7121831, and Part 456.637S, lot #7121832, with an expiration date of 11/30/21.
The products were distributed nationwide, including to Washington, Florida, Louisiana, Texas, Georgia, Indiana, Ohio, California, Michigan, and Pennsylvania. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 12
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 456.475S
- lot # 7121831 and Part 456.637S
- lot #7121832
- expiration 11/30/21.
Distribution
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