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