Synthes Trauma Nail System Recalled for Potential Outer Pouch Compromise
Synthes USA HQ, Inc. is recalling Trauma Nail Systems because the outer packaging pouch may be compromised, potentially affecting the sterile internal pouch.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a potential packaging compromise, which is a precautionary measure to ensure sterility, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Synthes USA HQ, Inc. is recalling the Synthes Trauma Nail System, a medical device indicated for bone fixation. The recall involves 1,011,783 units distributed nationwide. The specific products affected include Trauma Ex Nails with all lot numbers up to and including lot # 7072305, and Trochanteric Fixation Nails with all lot numbers up to and including lot # 7060897.
The recall was initiated due to the possibility that the outer packaging pouch was compromised. These devices are packaged in two pouches: a sterile internal pouch contained within an external pouch. The issue specifically concerns the outer, external pouch, which may be damaged or compromised.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these devices if the outer pouch integrity is in question. The source text does not provide specific instructions for disposal or replacement, but standard medical device recall procedures apply.
The recalled product
- Product
- Synthes Trauma Nail System. The devices are indication for bone fixation.
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 1,011,783
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)
- Trauma Ex Nails
- all lot numbers up to and including lot # 7060897
Distribution
Distributed nationwide across the United States.
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