Zavation: Medical Device Recall in 2021 - (Recall #: Z-1729-2021)

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 Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.

Product Classification:

Class II

Date Initiated: March 25, 2021

Date Posted: June 9, 2021

Recall Number: Z-1729-2021

Event ID: 87661

Reason for Recall:

Products distributed as sterile may not have been adequately sterilized

Status: Terminated

Product Quantity: 15 units

Code Information:

Lot: 20071774, 19123262

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated