The Recall Desk
HighFDA (Devices)·Z-0483-2025·Announced 2024-11-27

Hip Prosthesis Mislabeled with Wrong Size; Risk of Joint Instability

Novosource is recalling NovoHip Total Hip System units (lot CER0023) packaged in boxes labeled 32 long but containing 28 long components. If implanted, the wrong size may cause joint instability.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device (hip prosthesis) where mislabeling could result in joint instability if implanted with the wrong size. While FDA Class II, no hospitalizations or injuries have been reported, meeting the criteria for High severity: "risk-of-harm products where injury has not yet been reported."

Plain-English summary

Novosource, LLC is recalling certain NovoHip Biolox Ball Head components (Reference 1345-2803, Lot CER0023) from the NovoHip Total Hip System. These units are packaged in boxes labeled "32 long" but contain femoral heads physically marked as "28 long."

This mislabeling could result in joint instability if the wrong-sized component is implanted during surgery. The incorrect size may not properly fit within the patient's hip joint, affecting prosthesis stability and function.

The affected lot (UDI-DI 00811382037849) was distributed to Florida and West Virginia. Surgeons and healthcare facilities with these units in inventory should verify that the actual device size matches the box label before performing any implantation procedures. If any of these devices have already been implanted, the patient's surgeon should be consulted about next steps.

The recalled product

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 shel
Manufacturer
Novosource, LLC
Category
Medical Device — Hip Prosthesis
Hazard
  • mis-labeling
  • joint-instability

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI 00811382037849
  • Lot Number CER0023

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category