Recall Z-2235-2019 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
| Date | Jul 2, 2019 |
| Status | Terminated |
| Reason | Cleaning processes potentially being ineffective |
| Root cause | Material/Component Contamination |
| Action | Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Certificate of Acknowledgement and send to Corporate Quality. PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall |
| Quantity | 30 |
| Distribution | Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial Biomet Manufacturing, LLC, Jun 25, 2015 |