VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indica
FDA device recall Z-0277-2014 · posted 2013-11-14 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 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, Germa
- Date initiated
- 2013-08-28
- Date posted
- 2013-11-14
- Date terminated
- 2015-04-30
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HERITAGE HIP SYSTEM (K963109) | Zimmer, Inc. | 1997-01-09 |
| MODULAR CALCAR REPLACEMENT (K913649) | Zimmer, Inc. | 1991-11-13 |