DePuy Synthes Titanium Recon Screws Recalled for Incorrect Insert
Synthes, Inc. is recalling 276 DePuy Synthes 6.5 mm Titanium Recon Screws because certain lots contain the wrong insert.
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. The source text describes a component mismatch (incorrect insert) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes, Inc. is recalling 276 units of DePuy Synthes 6.5 mm Titanium Recon Screws with T25 Stardrive. These screws are part of the Expert Lateral Femur Nail System and are indicated to stabilize subtrochanteric fractures, ipsilateral neck/shaft fractures, femoral shaft fractures, impending pathologic fractures, and malunions/non-unions. The affected screws are available in lengths of 70mm, 75mm, 80mm, 85mm, 90mm, 95mm, and 105mm.
The recall was initiated because certain lots of the Titanium Recon Screws were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System) instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components). The affected part numbers are 04.003.024, 04.003.025, 04.003.026, 04.003.027, 04.003.028, 04.003.029, and 04.003.031. The specific lot numbers involved are 8638958, 8638957, 8534954, 8638955, 8556020, 8556018, 8653032, and 8653036.
The product was distributed nationwide. Healthcare providers and facilities should check their inventory for these specific part and lot numbers and stop using the affected devices. Consumers who have had these devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending…
- Manufacturer
- Synthes, Inc.
- Affected units
- 276
Distribution
Distributed nationwide across the United States.
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