VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
FDA Recall Z-0277-2014 · Posted 2013-11-14
Advertisement
Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2013-08-28
Date Terminated2015-04-30
Product Quantity12866 units
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
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
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, Nicaragua, Portugal, Saudi Arabia, Seoul Korea, Serbia, Singapore, South Africa, Spain, Switzerland, Turkey, Utd.Arab.Emir., United Kingdom, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement