Novosource, LLC: 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.

Recall number

Z-0483-2025

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.

Status

Open, Classified

Initiated

2024-09-19

Posted

2024-11-18

Terminated

not on file

Reason

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

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

1 unit

Distribution

Florida, West Virginia

Lot, serial or model codes

UDI-DI 00811382037849; Lot Number CER0023

510(k) numbers

["K132158"]

PMA numbers

not on file

Product code

LPH

Firm FEI

9989232

Firm city

Morgantown

Firm state

WV

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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