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 ZVplasty Unipedicular Cement Delivery Cannula Kits distributed nationwide due to potential inadequate sterilization of sterile surgical devices.
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Patients who received these devices should contact their healthcare provider.
Zavation is recalling ZVplasty Direct Access Diamond Tip Trocar (REF VCF-1023) distributed nationwide because products marketed as sterile may not have been adequately sterilized. The device is used in orthopedic and spinal procedures.
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's ZVplasty Biopsy Device (11 Gauge, lot 20061370) is being recalled because distributed units may not have been adequately sterilized. The 34 affected units were distributed nationwide.
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits due to inadequate sterilization. Products distributed as sterile nationwide may pose infection risk if used in spinal procedures.
Zavation is recalling 31 ZVplasty System spinal implant devices that may not have been adequately sterilized. Patients who received these implants should contact their physician.
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 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 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 is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Affected lot numbers 19113043 and 20041107 were distributed nationwide.
Zavation recalled 98 surgical trocars that may not be adequately sterilized. Products were distributed as sterile but may pose infection risks from inadequate sterilization.
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 System 15mm orthopedic spinal implants because products distributed as sterile may not have been adequately sterilized. Affected lot numbers were distributed nationwide.
Zavation has recalled 10 gauge direct unilateral sterile stylets used in orthopedic and spinal procedures due to inadequate sterilization. Products distributed as sterile may not meet sterilization standards.
Zavation recalled 197 CEMIX cement mixing system units due to inadequate sterilization for orthopedic and spinal surgical use.
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 is recalling InterV 10G Bone Access Tools (Lot 11613ZV) distributed nationwide because they may not have been adequately sterilized. No illnesses have been reported.
Zavation is recalling its 10G Single Cement Delivery Kit used in spinal procedures because products distributed as sterile may not have been adequately sterilized. This is an FDA Class II recall.
Zavation recalled ZVplasty Bipedicular Cement Delivery Cannulas (Lot 19123174) because products distributed as sterile may not have been adequately sterilized. These cannulas are used in spinal procedures; inadequate sterilization poses an infection risk.
Zavation's ZVplasty spinal surgical kit is being recalled because distributed units may not have been adequately sterilized. The recall affects 302 units distributed nationwide.
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 56 units of 10 Gauge Direct Unilateral Stylets used in spinal procedures because products distributed as sterile may not have been adequately sterilized. Patients who received this device should contact their healthcare provider.
Zavation's 10G Coaxial Cannulas for spinal procedures may not have been adequately sterilized. The nationwide recall addresses potential infection risk from non-sterile surgical instruments.
Zavation's 10G Coaxial Cannula with Tuohy Connection (Lot 20102495) used in spinal and orthopedic procedures has been recalled due to inadequate sterilization. Patients should contact their healthcare provider if they received this product.