FDA (Devices) recall action 87661
The FDA (Devices) publishes a recall like this one as 71 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 71 pages.
Products distributed as sterile may not have been adequately sterilized
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zavation is recalling 335 units of ZVplasty Direct Access Beveled Tip Trocars (10 Gauge) used in orthopedic and spinal procedures because affected units may not have been adequately sterilized.
Zavation recalled its 10G Direct Double Bone Access Kit used in orthopedic surgery because products distributed as sterile may not have been adequately sterilized, potentially exposing patients to infection.
Zavation is recalling ZVplasty System 15mm orthopedic spinal implants because products distributed as sterile may not have been adequately sterilized. Affected lot numbers were distributed nationwide.
Zavation is recalling 24 units of the ZVplasty System used in orthopedic and spinal procedures due to potential inadequate sterilization. Patients who received recalled devices should contact their healthcare provider.
Zavation is recalling 10G Double Cement Delivery Kits used in orthopedic and spinal procedures due to potential inadequate sterilization, creating a risk of surgical site infection.
Zavation recalled its 10G Direct Double Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. Affected devices are used in orthopedic and spinal procedures.
Zavation is recalling 119 InterV 11G Kyphoplasty Kits distributed nationwide because they may not have been adequately sterilized, which could increase the risk of infection during spinal surgery.
Zavation's ZVplasty System surgical devices may not have been adequately sterilized, creating infection risk. The recall affects 195 units distributed nationwide in the US across multiple lot numbers.
Zavation is recalling its 10G Cement Delivery Cannula used in orthopedic and spinal procedures nationwide due to products distributed as sterile not being adequately sterilized.
Zavation's InterV 10G FLEX Kyphoplasty spinal devices are recalled because they may not have been adequately sterilized. The recall affects 178 units distributed nationwide.
Zavation recalls ZVplasty 10G, 10mm Double Balloon Kits used in spinal surgery due to potential inadequate sterilization. Seven units distributed nationwide may not have met sterility standards.
Zavation is recalling InterV CurvePlus surgical kits because products distributed as sterile may not have been adequately sterilized. 36 units were distributed nationwide.
Zavation is recalling 11G Beveled Trocars/Cannulas for orthopedic and spinal procedures. These surgical instruments may not have been adequately sterilized, posing a potential safety risk.
Zavation recalled ZVplasty Drill units (REF VCF-1006, batch 19113036) distributed nationwide. The 38 affected units may not have been adequately sterilized, creating a risk of infection.
Zavation is recalling ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) because some units may not be adequately sterilized. These surgical instruments are used in orthopedic and spinal procedures.
Zavation has recalled 140 units of its Vertebrex Single Balloon Kit used in spinal procedures due to inadequate sterilization. Products marketed as sterile may not meet sterility standards.
Zavation recalled its 10-gauge orthopedic cement delivery system because products distributed as sterile may not have been adequately sterilized. Healthcare providers and patients with concerns should contact Zavation.
Zavation recalls orthopedic spinal devices distributed as sterile but potentially inadequately sterilized. Patients who received these devices should consult their healthcare provider.
Zavation is recalling ZVplasty Direct Access Bevel Tip Trocars used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. The recall affects 98 units distributed nationwide.
Zavation is recalling 27 units of ZVplasty Directional Cement Cannula Long (Lot 20061365) used in orthopedic and spinal procedures due to inadequate sterilization. Products were distributed nationwide as sterile but may not have undergone proper sterilization processing.
Zavation's 10G cement delivery kits for spinal procedures may not be adequately sterilized despite being marketed as sterile. Patients and healthcare providers should contact Zavation regarding potentially affected units.
Zavation is recalling 162 units of the ZVplasty Biopsy Device (Lot 20061369) used in orthopedic and spinal procedures because they may not have been adequately sterilized.
Zavation's 11G Direct Double Bone Access Kit for spinal and orthopedic procedures may not have been adequately sterilized during manufacturing. Distributed nationwide, the non-sterile devices may pose infection risks to patients.
Zavation is recalling 113 units of ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) due to inadequate sterilization. The devices were distributed nationwide and may not be safe for use in orthopedic and spinal procedures.
Zavation is recalling ZVPlasty spinal orthopedic devices that may not have been properly sterilized, creating a risk of infection. The recall affects 49 units distributed nationwide.