NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented
Summary
The FDA issued a Class II for NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - Nov by Novosource, LLC. 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.
Details
Source
Device Recall
External ID
Z-0483-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI-DI 00811382037849; Lot Number CER0023
Quantity Affected: 1 unit
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
Distribution
Florida, West Virginia
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-19
Company
Morgantown, WV
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novosource, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novosource, LLC have FDA actions?
This is the only FDA action we have on record for Novosource, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0483-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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