Data Foundry

Medical device recalls 2018

GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT — Class II medical device recall Z-2883-2018

Terminated recall by Smith & Nephew, Inc., reported 2018-08-29. Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R

Recall numberZ-2883-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSmith & Nephew, Inc., Memphis, TN, United States
Recall initiated2017-08-01
Classified2018-08-22
Reported by FDA2018-08-29
Terminated2019-02-19
Countries outside the USAT, AU, DE, ES, GB, PL
Quantity27 units
Lot numbers16CMB0061A, 16CMB0066A
Model numbers71420026

Product

GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis

Reason for recall

Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.

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-2883-2018. 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.