Synthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
Synthes USA is recalling 17 units of the Titanium Trochanteric Fixation Nail (TFN) System because two lots are missing a required second bend in the nail.
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. Per the rubric, FDA Class II recalls involving structural defects in medical devices are categorized as Severe (Score 4), particularly when significant injury or property damage reports are associated with the defect type.
Plain-English summary
Synthes USA HQ, Inc. is recalling 17 units of the Titanium Trochanteric Fixation Nail (TFN) System. The recall affects two specific lots of the device, which is intended to treat stable and unstable fractures of the proximal femur.
The recall was initiated because the nails in these two lots are missing the second bend. The affected units are identified by Part # 456.391S with lot numbers 5536930 (expiration date 5/20/2016) and 7161401 (expiration date 12/31/2021).
The affected products were distributed nationwide, including in Illinois, California, Arizona, Florida, Texas, Utah, Virginia, New York, New Mexico, and Montana. Healthcare providers and patients should contact Synthes USA for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 17
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 (4)
- Part # 456.391S with lot numbers 5536930
- exp. 5/20/2016
- and 7161401
- exp. 12/31/2021.
Distribution
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