Recall Z-0119-2016 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Gmbh
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
| Date | Oct 14, 2015 (initiated Sep 3, 2015) |
| Status | Terminated |
| Reason | In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection. |
| Root cause | Package design/selection |
| Action | On 9/3/2015, URGENT MEDICAL DEVICE RECALL notifications were sent via courier to the affected distributors and Hospital Risk Managers with instructions for locating and inspecting the affected devices and contacting Zimmer if damage is observed. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have questions concerning this notification, please call 1-877-946-2761. |
| Quantity | 57,603 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091566 | ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Zimmer GmbH, Oct 28, 2009 |