Synthes Recalls Titanium Trochanteric Fixation Nails Due to Assembly Error
Synthes, Inc. is recalling six sterile titanium trochanteric fixation nails due to incorrect assembly that may compromise bone stability.
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 3/5 (High).
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 high-risk medical device where an assembly error may lead to non-union or malunion, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Synthes, Inc. is recalling six units of the 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile). The product is intended to treat stable and unstable fractures of the proximal femur. The recall involves part number 456.316S and lot number 7782247.
The recall was initiated because the devices were assembled incorrectly. If this non-conformance goes undetected, it may impact the locking function after surgery. This could compromise bone reduction and construct stability, potentially leading to non-union or malunion of the fracture.
The affected units were distributed in the United States to the states of Alaska, Florida, Ohio, Oklahoma, and Texas. Healthcare providers and patients should contact Synthes, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
- Manufacturer
- Synthes, Inc.
- Affected units
- 6
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)
- part number: 456.316S
- lot number: 7782247
Distribution
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