Zavation: Medical Device Recall in 2021 - (Recall #: Z-1764-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.

Product Classification:

Class II

Date Initiated: March 25, 2021

Date Posted: June 9, 2021

Recall Number: Z-1764-2021

Event ID: 87661

Reason for Recall:

Products distributed as sterile may not have been adequately sterilized

Status: Terminated

Product Quantity: 79 units

Code Information:

Lot Numbers: 13877ZV, 13661ZV, 13388ZV, 12897ZV, 12764ZV, 12542ZV, 14391ZV, 14287ZV, 13004ZV, 10951ZV, 14016ZV

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated