Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect
Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Procedure Packs because the vitrectomy cutters do not operate within the correct pressure pulse specifications.
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 functional defect (pressure pulse specification) that poses a risk of harm during surgical procedures, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Procedure Packs with Mid-Field Illuminator, Product/Part Number 70025S. The devices are packaged in HIPS rigid trays with a Tyvek lid sterile barrier system. The recall involves two specific lots: M548370 (expiration 11/2018) and M578150 (expiration 02/2019).
The recall was initiated because the vitrectomy cutters were found not to be operating within the correct pressure pulse per specification. This defect affects the performance of the surgical instruments contained in the procedure packs.
The affected devices were distributed to healthcare facilities in Kentucky, Virginia, Tennessee, Ohio, Indiana, California, New Jersey, New York, Texas, South Carolina, Alabama, Mississippi, Michigan, and Utah. Additionally, the devices were distributed to the United Kingdom, France, Mexico, and India. Healthcare providers should stop using these specific lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Manufacturer
- Synergetics Inc
- Hazard
- Affected units
- 72
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 (3)
- Lot number M548370 (1 each or box of 6 each)
- exp 11/2018 Lot number M578150 (1 each or box of 6 each)
- exp 02/2019
Distribution
Part of a larger recall action
This product is one of 4 recalled by Synergetics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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