Synthes Inserter for Titanium Elastic Nails Recalled for Mechanical Failure
Synthes, Inc. is recalling Inserter for Titanium Elastic Nails due to potential mechanical failures including shaft breakage and chuck malfunction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with potential for mechanical failure (breakage, jamming) which poses a risk of harm during surgical procedures, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes, Inc. is recalling the Inserter for Titanium Elastic Nails (TEN) because the device has the potential for mechanical failures. The identified issues include breakage of the main shaft of the Inserter, malfunction of the chuck where it may get stuck or jammed, and breakage of the cross bar of the Inserter.
The Inserter for Titanium Elastic Nails is intended for the fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes lower extremity fractures in pediatric and small-statured patients, upper extremity fractures, and the treatment of metaphyseal and episphyseal fractures such as radial neck fractures. The system is also intended for the fixation of small long bones, such as carpal and tarsal bones.
The recall involves 1,550 units distributed nationwide. Affected units are identified by Part Number 359.219 and specific sold and manufacturing lot numbers listed in the agency's recall record. Consumers and healthcare providers should stop using the affected devices and contact Synthes, Inc. for further instructions.
The recalled product
- Product
- Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statu
- Manufacturer
- Synthes, Inc.
- Affected units
- 1,550
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 (1)
- Part Number: 359.219
Distribution
Distributed nationwide across the United States.
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