Synthes Sternal Zip Flex System Recalled for Implant Cutting Risk
Synthes USA HQ, Inc. is recalling 319 units of the Sternal Zip Flex System because the application instrument may cut the implant, leading to loosening.
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 agency classification is FDA Class II, and the defect involves a structural failure of a medical implant (loosening) which poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Synthes USA HQ, Inc. is recalling 319 units of the Synthes Application Instrument Sternal Zip Flex System. This medical device is intended for the primary or secondary closure and repair of the sternum following sternotomy or fracture to stabilize the sternum and promote fusion.
The recall is being issued because it is possible to cut the implant while the tensioning trigger of the 1st generation Zip Fix Application Instrument is being squeezed. This defect could lead to the loosening of the implant.
The affected units were distributed nationwide in the United States and in Mexico. The recall covers Part No. 03.501.080 with multiple specific lot numbers. Healthcare providers and patients should contact Synthes USA HQ, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 319
Distribution
Distributed nationwide across the United States.
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