medical Class II Updated 2024-11-27

Novosource, LLC recalls NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip To

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Florida, West Virginia
Lot/Code Info: UDI-DI 00811382037849; Lot Number CER0023
View official government recall

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