Zavation: Medical Device Recall in 2021 - (Recall #: Z-1713-2021)

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-1713-2021
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: 19123262, 20071774

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated