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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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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