Recall Z-0119-2016— Zimmer Gmbh

Name: FDA recall Z-0119-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-03

Class II · Terminated

Class II FDA medical device recall by Zimmer Gmbh, initiated 2015-09-03, terminated 2016-03-15. It names one FDA 510(k) clearance: K091566. Product: Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.. 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..

Recalling firm: Zimmer Gmbh
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Terminated: 2016-03-15
Firm location: Winterthur, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K091566 — ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILSZimmer GmbH·cleared 2009-10-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.