FDA recall Z-0933-2021

Product

VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.

Reason for recall

Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.

Distribution

Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.

Key facts

Status

Terminated

Initiation date

2020-12-18

Report date

2021-02-10

Termination date

2023-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0933-2021