Zavation: Medical Device Recall in 2021 - (Recall #: Z-1756-2021)

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:

OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.

Product Classification:

Class II

Date Initiated: March 25, 2021

Date Posted: June 9, 2021

Recall Number: Z-1756-2021

Event ID: 87661

Reason for Recall:

Products distributed as sterile may not have been adequately sterilized

Status: Terminated

Product Quantity: 200 units

Code Information:

a) INTV-OSFL, Lot Numbers: 11395ZV, 11285ZV, 11574ZV, 11471ZV b) INTV-OSFL-LV, Lot Numbers: 12386ZV

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated