Synthes Sternal ZIPFIX Application Instrument Recall for Screw Failure Risk
Synthes is recalling 267 previously repaired Sternal ZIPFIX Application Instruments because the screws may break or loosen.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect (screws breaking or loosening) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Synthes (USA) Products LLC is recalling 267 units of the Application Instrument for Sternal ZIPFIX. These specific instruments were part of a previous recall on August 19, 2015, were subsequently repaired, and returned to customers between August 26, 2015, and September 23, 2015.
The recall is being issued because the screws on the repaired instruments have the potential to break or loosen. The affected devices are identified by Part Number 03.501.080 and specific lot numbers listed in the agency record.
The devices were distributed in Kentucky, Utah, California, Wisconsin, Ohio, Colorado, Illinois, Texas, Oklahoma, Washington, Michigan, Louisiana, Massachusetts, Pennsylvania, and Nebraska. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.
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
- 267
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)
- Synthes Application Instrument for Sternal ZIPFIX
- Part Number 03.501.080. Lot Numbers 3783913
- 7516728
- 7606881
- 7659168
- 7666085
- 7671934
- 7689244
- 7694377
- 7720599
- 7738572
- 7738573
- 7740498
- 7767497
- 7803768
- 7806881
- 7818677
- 7818682
- 7821672
- 7827088
Distribution
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