FDA-Device2021-08-18Class II
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Exactech, Inc.
Hazard
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
Sold states
US Nationwide Distribution
Affected count
30 devices
Manufactured in
2320 Nw 66th Ct, N/A, Gainesville, FL, United States
Products
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2251-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief