Reported Feb 10, 2021 · Terminated
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage:…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
- VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement
- Product Number71271440 -
- Product UsageVERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin
- Lot codes and dates
- Product Number71271440
- Batch Number18LC07540
- Amount recalled
- 5190 devices
Where it was sold
Why it was recalled
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
This product could cause temporary or reversible health problems — stop using it.
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