Recall Z-2820-2018 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Biomet, Inc.
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
| Date | Jun 8, 2018 |
| Status | Terminated |
| Reason | Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component. |
| Root cause | Process control |
| Action | The firm sent an initial email on June 6, 2018, to US distributors that received affected product. Distributors were asked to quarantine any affected product on hand. The formal recall notice was then prepared and emailed to distributors on June 8, 2018. On the same day, hospital risk managers and distributors received notification via courier. " The distributors notice identified the issue and their responsibilities. These responsibilities included locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. " Distributors will |
| Quantity | 12 |
| Distribution | US distribution to CA, GA, IL, MO, NY, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090757 | BIOMET MODULAR FEMORAL REVISION SYSTEM Biomet, Inc., Sep 25, 2009 |