Synthes Titanium Humeral Nail Recalled for Incorrect Packaging Labeling
Synthes USA is recalling 14 Titanium Cannulated Humeral Nails because the packaging incorrectly depicts the device as having 3 distal holes instead of 2.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a packaging-only labeling error with no reported injuries or illnesses, fitting the rubric criteria for cosmetic or documentation issues.
Plain-English summary
Synthes USA HQ, Inc. is recalling 14 units of the Synthes Titanium Cannulated Humeral Nail. The device is intended to aid in the alignment and stabilization of humeral fractures.
The recall was initiated because the packaging incorrectly depicts the nail as a 3 distal hole nail, whereas the actual device is a 2 distal locking hole nail. This is a labeling error on the packaging.
The affected units were distributed nationwide in the United States, including in South Carolina, Iowa, North Carolina, Texas, Kentucky, Virginia, Alabama, and Pennsylvania, as well as internationally to Canada. The specific part and lot numbers are listed in the structured product information. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 14
Distribution
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