Recall Z-0483-2025— Novosource, LLC
Class II · Ongoing
Class II FDA medical device recall by Novosource, LLC, initiated 2024-09-19. It names one FDA 510(k) clearance: K132158. 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.. 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.
- Recalling firm
- Novosource, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-19
- Firm location
- Morgantown, WV, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.