Recall Z-0933-2021— Smith & Nephew, Inc.

Name: FDA recall Z-0933-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-18

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-12-18, terminated 2023-05-01. It names one FDA 510(k) clearance: K022688. 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: Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-18
Terminated: 2023-05-01
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K022688 — VERSABOND AB BONE CEMENTSmith & Nephew, Inc.·cleared 2004-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.