Recall Z-0548-2018 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intra
| Date | Jun 5, 2017 |
| Status | Terminated |
| Reason | The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed. |
| Root cause | Package design/selection |
| Action | On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via FedEx and email. **Hospital Risk Managers are advised to:** 1. Review this notification and ensure affected team members are aware of the contents. 2. Complete the Certification of Acknowledgement portion of Attachment 1 a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 3. Assist your Zimmer Biomet sales representative quarantine all affected product. **Distributors are advised to:** 1. Review this notification and ensure affected personnel ar |
| Quantity | 1,517 units |
| Distribution | Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.