Z-0933-2021 Class II Terminated
FDA device recall Z-0933-2021 was initiated by Smith & Nephew, Inc. on December 18, 2020 and is designated Class II. Reason for recall: Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing. The recall status is terminated (terminated May 1, 2023). Affected quantity: 5190 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2021
- Initiation Date
- December 18, 2020
- Termination Date
- May 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5190 devices
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.
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.
Code Information
Product Number: 71271440; Batch Number: 18LC07540