FDA-Device2024-11-27Class II
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components.
Novosource, LLC
Hazard
Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted
Sold states
Florida, West Virginia
Affected count
1 unit
Manufactured in
2000 Hampton Ctr Ste C, N/A, Morgantown, WV, United States
Products
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0483-2025Don't want to check this manually?
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