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Recall Observatory FDA recall evidence

Device 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.

Z-0933-2021

December 18, 2020

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 87035
Status
Terminated
Classification
Class II
Quantity
5190 devices
Official record key
device-enforcement:Z-0933-2021

Official wording

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

Code information: Product Number: 71271440; Batch Number: 18LC07540

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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