GENESIS — Class II medical device recall Z-1996-2013
Terminated recall by Smith & Nephew Inc, reported 2013-08-28. The products were produced using the wrong color material, resulting in the devices being red (used for deep d
| Recall number | Z-1996-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2013-07-08 |
| Classified | 2013-08-21 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2019-08-19 |
| Countries outside the US | AE, DE, FR, GB |
| Quantity | 9 units |
| Lot numbers | 12LM03798 |
| Model numbers | 71430490 |
Product
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
Reason for recall
The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
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-1996-2013. 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.