Recall Z-0483-2025 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
| Date | Nov 18, 2024 (initiated Sep 19, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 1 unit |
| Distribution | Florida, West Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132158 | NOVOHIP TOTAL HIP SYSTEM Novosource, Inc., Feb 21, 2014 |