Z-0483-2025Class II

NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a...

Name: Z-0483-2025 NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a...
Creator: Novosource, LLC
Published: 2024-09-19
License: https://open.fda.gov/license/

Novosource, LLC / initiated 2024-09-19 / Open, Classified / root cause: labeling and UDI

FDA source

Novosource, LLC began a recall of 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... on 2024-09-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0483-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-19
Posted: 2024-11-18
Recalling firm: Novosource, LLC
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.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: NovoSource LLC issued Urgent Medical Device Recall letter on 9/13/24 via email. Letter states reason for recall, health risk and action to take: "Immediate Action Discontinue Use: All customers and healthcare providers should immediately discontinue the use of the affected product batches. Surgical teams should not use any Biolox Delta Ceramic Head implants from the mislabeling-affected batches in any hip replacement surgeries. "Return or Segregation of Affected Product: Affected implants should be removed from active inventory and returned to NovoSource. Providers should follow instructions for proper packaging and shipping of the returned products. Any products not yet returned should be clearly labeled as "Do Not Use" and quarantined from inventory until shipment back to NovoSource. Instructions on how to return products will be provided, including the appropriate return address and contact person for support during this process. " For Unused Products: Customers should ensure that all unused products from the affected batches are returned to NovoSource. This will prevent any risk of improper head-liner fitting due to the mislabeling. "For Implanted Products: If the mislabeled product has already been implanted, surgeons should be prepared to monitor the patient for symptoms consistent with the mismatch. A mismatch of a 32 long head implanted into a 28 liner would likely have instability issues. A 28 long head implanted into a 32 liner will likely act very similarly in stability and alignment, while wear should not be catastrophic. The surgeon should monitor the patient to determine if symptoms appear that would result in the need to revise. Actions to Be Taken Pending Corrective or Removal Action: "Stop Usage: Healthcare facilities should stop any further use of the affected product batches pending completion of the recall process. NovoSource will provide updates on the investigation and resolution. "Notification to Surgical Teams: IF IMPLANTED, it is essential
Quantity in commerce: 1 unit
Distribution: Florida, West Virginia
Product codes and lots: UDI-DI 00811382037849; Lot Number CER0023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0483-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0483-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-18

Product code LPH

K132158Class IINovohip Total Hip SystemNovosource, Inc. / cleared 2014-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)