Zavation: Medical Device Recall in 2021 - (Recall #: Z-1755-2021)

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 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.

Product Classification:

Class II

Date Initiated: March 25, 2021

Date Posted: June 9, 2021

Recall Number: Z-1755-2021

Event ID: 87661

Reason for Recall:

Products distributed as sterile may not have been adequately sterilized

Status: Terminated

Product Quantity: 119 units

Code Information:

a) INTVMN-10-DSK, Lot Numbers: 12200ZV b) INTVMN-15-DSK, Lot Numbers: 10816ZV, 13708ZV, 13845ZV, 13522ZV, 12133ZV c) INTVMN-15-DSKC, Lot Numbers: 11843ZV, 11412ZV, 11160ZV, 11017ZV d) INTVMN-20-DSK, Lot Numbers: 14266ZV, 14238ZV, 12524ZV, 11756ZV, 11083ZV

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated