Synthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk
Synthes (USA) Products LLC is recalling 1,550 Inserter for Titanium Elastic Nails (TEN) devices due to a potential for mechanical failures such as breakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (mechanical failure/breakage) in an orthopedic device, which meets the criteria for a Severe rating.
Plain-English summary
Synthes (USA) Products LLC is recalling 1,550 units of the Inserter for Titanium Elastic Nails (TEN), an orthopedic medical device. The recall is issued because of a potential for mechanical failures, specifically breakage, associated with the device.
The affected products were distributed nationwide in the United States and internationally to Australia. The recall covers specific part numbers and lot numbers identified by the manufacturer.
Healthcare providers and facilities should stop using the affected devices and contact Synthes (USA) Products LLC for further instructions on handling the recalled items.
The recalled product
- Product
- Inserter for Titanium Elastic Nails (TEN), orthopedic device
- Manufacturer
- Synthes (USA) Products LLC
- Category
- Medical Device — Orthopedic
- Affected units
- 1,550
Distribution
Distributed nationwide across the United States.
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