Zavation: Medical Device Recall in 2021 - (Recall #: Z-1752-2021)

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:

InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.

Product Classification:

Class II

Date Initiated: March 25, 2021

Date Posted: June 9, 2021

Recall Number: Z-1752-2021

Event ID: 87661

Reason for Recall:

Products distributed as sterile may not have been adequately sterilized

Status: Terminated

Product Quantity: 178 units

Code Information:

a) INTVM-15-FLDSK, Lot Numbers:10342ZV, 12525ZV, 12267ZV, 12011ZV, 10545ZV, 10048ZV, 11861ZV, 11343ZV, 11037ZV, 10780ZV, 11102ZV b) INTVM-20-FLDSK, Lot Numbers: 10312ZV, 11698ZV, 10276ZV, 10205ZV, 10031ZV

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated