Recall Z-0630-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.
| Date | Oct 31, 2018 |
| Status | Terminated |
| Reason | Screw is missing from the package |
| Root cause | Process control |
| Action | Zimmer Biomet issued "URGENT MEDICAL DEVICE RECALL" Letter on 10/31/18 via email and FedEx to the consumer/user level, including any intermediate wholesale or retail consignees, distributors and Risk managers. Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals that have previously used the product. Hospital risk managers responsibilities include the following: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer B |
| Quantity | 19 units |
| Distribution | Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152494 | Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments Zimmer, Inc., Nov 25, 2015 |