Synthes Sternal ZIPFIX Application Instrument Recalled Due to Detaching End Cap
Synthes (USA) Products LLC is recalling 451 Sternal ZIPFIX Application Instruments because the end cap may loosen and detach, rendering the instrument non-functional.
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 hazard is a functional failure (non-functional instrument) with no reported injuries, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Synthes (USA) Products LLC is recalling 451 units of the Synthes Application Instrument for Sternal ZIPFIX. The instrument is indicated for primary or secondary closure or repair of the sternum following sternotomy or fracture to stabilize the sternum and promote fusion.
The recall was initiated because the end cap of the instrument may loosen and detach, which makes the instrument non-functional. The source text explicitly states that no injuries have been reported.
The affected units were distributed nationwide and internationally to Canada. The specific part number is 03.501.080, and the recall covers a specific list of lot numbers including 3783492, 3783913, and 3788496, among others. Users should stop using the affected instruments and contact the manufacturer for instructions.
The recalled product
- Product
- Synthes Application Instrument for Sternal ZIPFIX; indications for use include 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) Products LLC
- Hazard
- Affected units
- 451
Distribution
Distributed nationwide across the United States.
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