Synthes Recalls Titanium Trochanteric Fixation Nails Due to Missing Components
Synthes (USA) Products LLC is recalling 4 units of sterile titanium trochanteric fixation nails because the locking mechanism and protective cap were missing.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging/component defect rather than a high-risk pathogen or structural failure with reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 4 units of the 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile. The recall involves Lot H302839 with an expiration date of 31Jan2026. The affected units were distributed to facilities in Texas, Georgia, Pennsylvania, Utah, and Canada.
The recall was initiated because the locking mechanism and protective cap were missing from the sterile packed nails of the affected lot. This defect could compromise the integrity of the sterile packaging and the functionality of the medical device.
Healthcare facilities and consumers who have this specific product should stop using it and contact Synthes (USA) Products LLC for instructions on return or replacement.
The recalled product
- Product
- 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 4
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)
- Lot H302839
- Expiration Date 31Jan2026
Distribution
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