Recall Z-2235-2018 ยท HTY Pin, Fixation, Smooth
Zimmer Biomet, Inc.
BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
| Date | Jun 1, 2018 (initiated May 16, 2018) |
| Status | Terminated |
| Reason | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection. |
| Root cause | Under Investigation by firm |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2018 on May 16, 2018, to affected consignees via email and FedEx. The letter describes the product, problem and actions to be taken. Consignees were informed of the recall and instructed to take the following actions: Risk Manager Responsibilities: 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 Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative w |
| Quantity | 26 |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831005 | WIRE & STEINMAN PINS Kirschner Medical Corp., May 18, 1983 |