Recall Z-2216-2017 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Zimmer Biomet, Inc.
Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels al
| Date | Apr 26, 2017 |
| Status | Terminated |
| Reason | Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads. |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet initiated a voluntary recall on April 26, 2017, for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-conforming threads. Notices were distributed via FedEx to customers. Risk Managers were instructed as follows: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zim |
| Quantity | 16 |
| Distribution | Worldwide Distribution - US including OH AZ ID PA AR MN IL CA MD CA MN NY Foreign: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060694 | MODULAR HYBRID GLENOID Biomet Manufacturing Corp, Dec 11, 2006 |