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.
Reported: February 10, 2021 Initiated: December 18, 2020 #Z-0933-2021
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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 5190 devices
- 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.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smith & Nephew, Inc.. Units affected: 5190 devices.
Why was this product recalled? ▼
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Moderate. Recall number: Z-0933-2021.
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