Recall Z-0277-2014 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer, Inc.
VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
| Date | Nov 14, 2013 (initiated Aug 28, 2013) |
| Status | Terminated |
| Reason | Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provid |
| Root cause | Packaging process control |
| Action | Removal of the subject devices from the field including distributor and hospital inventories. Distributors and Risk Managers and Surgeons at hospitals that received a direct shipment from Zimmer or its Distributors received a notification on 09/19/2013. |
| Quantity | 12866 units |
| Distribution | Worldwide distribution: US (Nationwide) including Puerto Rico and Virgin Islands; and countries of: Australia, Algeria, Belgium, Bolivia, Canada, Canary Islands, Chile, Croatia, Finland, France, Germany, Greece, Guatemala, Honduras, India, Israel, Italy, Japan, Jordan, Lima-Peru, Malaysia, Morocco, |
| FDA record | Open on fda.gov |