RecallRadar

FDA Device recall Z-0933-2021

VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscos…

On 2021-02-10 the FDA classified a Class II recall of VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscos… by Smith And Nephew, citing potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0933-2021
ClassificationClass II
Statusterminated
Initiated2020-12-18
Published2021-02-10
Last updated2026-09-13 11:56 UTC
CompanySmith And Nephew
DistributionUS

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.

Identifiers

code_infoProduct Number: 71271440; Batch Number: 18LC07540

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0933-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.