Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
FDA Recall Z-0119-2016 · Posted 2015-10-14
Recalling FirmZimmer Gmbh
Recall StatusTerminated
Product CodeHSB
Date Initiated2015-09-03
Date Terminated2016-03-15
Product Quantity57,603 units
Reason for Recall
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.
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.