VERSABOND AB 40 GRAMS FORMULATION 2 — Class II medical device recall Z-0933-2021
Terminated recall by Smith & Nephew, Inc., reported 2021-02-10, distributed nationwide. Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistenc
| Recall number | Z-0933-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2020-12-18 |
| Classified | 2021-01-29 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2023-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CR, KR, PA |
| Quantity | 5,190 devices |
| Lot numbers | 18LC07540 |
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.
Reason for recall
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0933-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.