DePuy Synthes Recalls TFNA Blade/Screw Guide Sleeves Due to Sizing Defect
DePuy Synthes is voluntarily recalling TFNA Blade/Screw Guide Sleeves because a manufacturing defect may prevent proper use, potentially causing surgical delays.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the hazard is a potential surgical delay rather than a direct risk of serious injury or death, aligning with the 'Moderate' criteria for voluntary precautionary recalls without reported harm.
Plain-English summary
DePuy Synthes is initiating a voluntary recall of Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeves, Part Number 03.037.017. The recall involves 2,064 units manufactured between July 30, 2014, and July 1, 2015, which were distributed nationwide to hospitals and medical facilities across the United States and Puerto Rico.
The recall was initiated because the sleeves may have been manufactured with an outer diameter slightly larger than specified. This defect could prevent the sleeve from passing through the TFNA aiming arm properly, which may result in surgical delays during procedures for the treatment of intramedullary fixation of proximal femoral fractures.
Healthcare facilities and consumers should check their inventory for the specific part number and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to the instructions provided by DePuy Synthes.
The recalled product
- Product
- Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998…
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 2,064
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 (20)
- Catalog ID: 03.037.017 Lot Numbers: 9066399
- 9066435
- 9409790
- 9519308
- 9620447
- 9301183
- 9409792
- 9519303
- 9641077
- 9301184
- 9409791
- 9542998
- 9641078
- 9327510
- 9422885
- 9554330
- 9651850
- 9340629
- 9351396
- 9554329
Distribution
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