Z-0119-2016Class II

Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for...

Name: Z-0119-2016 Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for...
Creator: Zimmer Gmbh
Published: 2015-09-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-09-03 / Terminated / root cause: packaging

FDA source

Zimmer Gmbh began a recall of Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the... on 2015-09-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0119-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Posted: 2015-10-14
Terminated: 2016-03-15
Recalling firm: Zimmer GmbH
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.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: packaging
FDA 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 in commerce: 57,603 units
Distribution: US Nationwide distribution.
Product codes and lots: All Lots. Item number and name: 47-2493-481-10 ZNN CMN Nail 10mmX48cm 125 L 47-2493-442-10 ZNN CMN Nail 10mmX44cm 130 R 47-2493-480-10 ZNN CMN Nail 10mmX48cm 125 R 47-2493-445-10 ZNN CMN Nail 10mmX44cm 135 L 47-2493-483-10 ZNN CMN Nail 10mmX48cm 130 L 47-2493-444-10 ZNN CMN Nail 10mmX44cm 135 R 47-2493-482-10 ZNN CMN Nail 10mmX48cm 130 R 47-2493-441-11 ZNN CMN Nail 11.5mmX44cm 125 L 47-2493-485-10 ZNN CMN Nail 10mmX48cm 135 L 47-2493-440-11 ZNN CMN Nail 11.5mmX44cm 125 R 47-2493-484-10 ZNN CMN Nail 10mmX48cm 135 R 47-2493-443-11 ZNN CMN Nail 11.5mmX44cm 130 L 47-2493-481-11 ZNN CMN Nail 11.5mmX48cm 125 L 47-2493-442-11 ZNN CMN Nail 11.5mmX44cm 130 R 47-2493-480-11 ZNN CMN Nail 11.5mmX48cm 125 R 47-2493-445-11 ZNN CMN Nail 11.5mmX44cm 135 L 47-2493-483-11 ZNN CMN Nail 11.5mmX48cm 130 L 47-2493-444-11 ZNN CMN Nail 11.5mmX44cm 135 R 47-2493-482-11 ZNN CMN Nail 11.5mmX48cm 130 R 47-2493-441-13 ZNN CMN Nail 13mmX44cm 125 L 47-2493-485-11 ZNN CMN Nail 11.5mmX48cm 135 L 47-2493-440-13 ZNN CMN Nail 13mmX44cm 125 R 47-2493-484-11 ZNN CMN Nail 11.5mmX48cm 135 R 47-2493-443-13 ZNN CMN Nail 13mmX44cm 130 L 47-2493-481-13 ZNN CMN Nail 13mmX48cm 125 L 47-2493-442-13 ZNN CMN Nail 13mmX44cm 130 R 47-2493-480-13 ZNN CMN Nail 13mmX48cm 125 R 47-2493-445-13 ZNN CMN Nail 13mmX44cm 135 L 47-2493-483-13 ZNN CMN Nail 13mmX48cm 130 L 47-2493-444-13 ZNN CMN Nail 13mmX44cm 135 R 47-2493-482-13 ZNN CMN Nail 13mmX48cm 130 R 47-2493-421-10 ZNN CMN Nail 10mmX42cm 125 L 47-2493-485-13 ZNN CMN Nail 13mmX48cm 135 L 47-2493-420-10 ZNN CMN Nail 10mmX42cm 125 R 47-2493-484-13 ZNN CMN Nail 13mmX48cm 135 R 47-2493-423-10 ZNN CMN Nail 10mmX42cm 130 L 47-2493-463-13 ZNN CMN Nail 13mmX46cm 130 L 47-2493-422-10 ZNN CMN Nail 10mmX42cm 130 R 47-2493-461-10 ZNN CMN Nail 10mmX46cm 125 L 47-2493-425-10 ZNN CMN Nail 10mmX42cm 135 L 47-2493-460-10 ZNN CMN Nail 10mmX46cm 125 R 47-2493-424-10 ZNN CMN Nail 10mmX42cm 135 R 47-2493-463-10 ZNN CMN Nail 10mmX46cm 130 L 47-2493-421-11 ZNN CMN Nail 11.5mmX42cm 125 L 47-2493-462-10 ZNN CMN Nail 10mmX46cm 130 R 47-2493-420-11 ZNN CMN Nail 11.5mmX42cm 125 R 47-2493-465-10 ZNN CMN Nail 10mmX46cm 135 L 47-2493-423-11 ZNN CMN Nail 11.5mmX42cm 130 L 47-2493-464-10 ZNN CMN Nail 10mmX46cm 135 R 47-2493-422-11 ZNN CMN Nail 11.5mmX42cm 130 R 47-2493-461-11 ZNN CMN Nail 11.5mmX46cm 125 L 47-2493-425-11 ZNN CMN Nail 11.5mmX42cm 135 L 47-2493-460-11 ZNN CMN Nail 11.5mmX46cm 125 R 47-2493-424-11 ZNN CMN Nail 11.5mmX42cm 135 R 47-2493-463-11 ZNN CMN Nail 11.5mmX46cm 130 L 47-2493-421-13 ZNN CMN Nail 13mmX42cm 125 L 47-2493-462-11 ZNN CMN Nail 11.5mmX46cm 130 R 47-2493-420-13 ZNN CMN Nail 13mmX42cm 125 R 47-2493-465-11 ZNN CMN Nail 11.5mmX46cm 135 L 47-2493-423-13 ZNN CMN Nail 13mmX42cm 130 L 47-2493-464-11 ZNN CMN Nail 11.5mmX46cm 135 R 47-2493-422-13 ZNN CMN Nail 13mmX42cm 130 R 47-2493-461-13 ZNN CMN Nail 13mmX46cm 125 L 47-2493-425-13 ZNN CMN Nail 13mmX42cm 135 L 47-2493-460-13 ZNN CMN Nail 13mmX46cm 125 R 47-2493-424-13 ZNN CMN Nail 13mmX42cm 135 R 47-2493-462-13 ZNN CMN Nail 13mmX46cm 130 R 47-2493-401-10 ZNN CMN Nail 10mmX40cm 125 L 47-2493-465-13 ZNN CMN Nail 13mmX46cm 135 L 47-2493-400-10 ZNN CMN Nail 10mmX40cm 125 R 47-2493-464-13 ZNN CMN Nail 13mmX46cm 135 R 47-2493-403-10 ZNN CMN Nail 10mmX40cm 130 L 47-2493-441-10 ZNN CMN Nail 10mmX44cm 125 L 47-2493-402-10 ZNN CMN Nail 10mmX40cm 130 R 47-2493-440-10 ZNN CMN Nail 10mmX44cm 125 R 47-2493-405-10 ZNN CMN Nail 10mmX40cm 135 L 47-2493-443-10 ZNN CMN Nail 10mmX44cm 130 L 47-2493-404-10 ZNN CMN Nail 10mmX40cm 135 R 47-2493-401-11 ZNN CMN Nail 11.5mmX40cm 125 L 47-2493-340-10 ZNN CMN Nail 10mmX34cm 125 R 47-2493-400-11 ZNN CMN Nail 11.5mmX40cm 125 R 47-2493-343-10 ZNN CMN Nail 10mmX34cm 130 L 47-2493-403-11 ZNN CMN Nail 11.5mmX40cm 130 L 47-2493-342-10 ZNN CMN Nail 10mmX34cm 130 R 47-2493-402-11 ZNN CMN Nail 11.5mmX40cm 130 R 47-2493-341-11 ZNN CMN Nail 11.5mmX34cm 125 L 47-2493-405-11 ZNN CMN Nail 11.5mmX40cm 135 L 47-2493-340-11 ZNN CMN Nail 11.5mmX34cm 125 R 47-2493-404-11 ZNN CMN Nail 11.5mmX40cm 135 R 47-2493-343-11 ZNN CMN Nail 11.5mmX34cm 130 L 47-2493-401-13 ZNN CMN Nail 13mmX40cm 125 L 47-2493-342-11 ZNN CMN Nail 11.5mmX34cm 130 R 47-2493-400-13 ZNN CMN Nail 13mmX40cm 125 R 47-2493-341-13 ZNN CMN Nail 13mmX34cm 125 L 47-2493-403-13 ZNN CMN Nail 13mmX40cm 130 L 47-2493-340-13 ZNN CMN Nail 13mmX34cm 125 R 47-2493-402-13 ZNN CMN Nail 13mmX40cm 130 R 47-2493-343-13 ZNN CMN Nail 13mmX34cm 130 L 47-2493-405-13 ZNN CMN Nail 13mmX40cm 135 L 47-2493-342-13 ZNN CMN Nail 13mmX34cm 130 R 47-2493-404-13 ZNN CMN Nail 13mmX40cm 135 R 47-2493-321-10 ZNN CMN Nail 10mmX32cm 125 L 47-2493-381-10 ZNN CMN Nail 10mmX38cm 125 L 47-2493-320-10 ZNN CMN Nail 10mmX32cm 125 R 47-2493-380-10 ZNN CMN Nail 10mmX38cm 125 R 47-2493-323-10 ZNN CMN Nail 10mmX32cm 130 L 47-2493-383-10 ZNN CMN Nail 10mmX38cm 130 L 47-2493-322-10 ZNN CMN Nail 10mmX32cm 130 R 47-2493-382-10 ZNN CMN Nail 10mmX38cm 130 R 47-2493-321-11 ZNN CMN Nail 11.5mmX32cm 125 L 47-2493-381-11 ZNN CMN Nail 11.5mmX38cm 125 L 47-2493-320-11 ZNN CMN Nail 11.5mmX32cm 125 R 47-2493-380-11 ZNN CMN Nail 11.5mmX38cm 125 R 47-2493-323-11 ZNN CMN Nail 11.5mmX32cm 130 L 47-2493-383-11 ZNN CMN Nail 11.5mmX38cm 130 L 47-2493-322-11 ZNN CMN Nail 11.5mmX32cm 130 R 47-2493-382-11 ZNN CMN Nail 11.5mmX38cm 130 R 47-2493-321-13 ZNN CMN Nail 13mmX32cm 125 L 47-2493-381-13 ZNN CMN Nail 13mmX38cm 125 L 47-2493-320-13 ZNN CMN Nail 13mmX32cm 125 R 47-2493-380-13 ZNN CMN Nail 13mmX38cm 125 R 47-2493-323-13 ZNN CMN Nail 13mmX32cm 130 L 47-2493-383-13 ZNN CMN Nail 13mmX38cm 130 L 47-2493-322-13 ZNN CMN Nail 13mmX32cm 130 R 47-2493-382-13 ZNN CMN Nail 13mmX38cm 130 R 47-2493-301-10 ZNN CMN Nail 10mmX30cm 125 L 47-2493-361-10 ZNN CMN Nail 10mmX36cm 125 L 47-2493-300-10 ZNN CMN Nail 10mmX30cm 125 R 47-2493-360-10 ZNN CMN Nail 10mmX36cm 125 R 47-2493-303-10 ZNN CMN Nail 10mmX30cm 130 L 47-2493-363-10 ZNN CMN Nail 10mmX36cm 130 L 47-2493-302-10 ZNN CMN Nail 10mmX30cm 130 R 47-2493-362-10 ZNN CMN Nail 10mmX36cm 130 R 47-2493-301-11 ZNN CMN Nail 11.5mmX30cm 125 L 47-2493-361-11 ZNN CMN Nail 11.5mmX36cm 125 L 47-2493-300-11 ZNN CMN Nail 11.5mmX30cm 125 R 47-2493-360-11 ZNN CMN Nail 11.5mmX36cm 125 R 47-2493-303-11 ZNN CMN Nail 11.5mmX30cm 130 L 47-2493-363-11 ZNN CMN Nail 11.5mmX36cm 130 L 47-2493-302-11 ZNN CMN Nail 11.5mmX30cm 130 R 47-2493-362-11 ZNN CMN Nail 11.5mmX36cm 130 R 47-2493-301-13 ZNN CMN Nail 13mmX30cm 125 L 47-2493-361-13 ZNN CMN Nail 13mmX36cm 125 L 47-2493-300-13 ZNN CMN Nail 13mmX30cm 125 R 47-2493-360-13 ZNN CMN Nail 13mmX36cm 125 R 47-2493-303-13 ZNN CMN Nail 13mmX30cm 130 L 47-2493-363-13 ZNN CMN Nail 13mmX36cm 130 L 47-2493-302-13 ZNN CMN Nail 13mmX30cm 130 R 47-2493-362-13 ZNN CMN Nail 13mmX36cm 130 R 47-2493-305-10 ZNN CMN Nail 10mmX30cm 135 L 47-2493-341-10 ZNN CMN Nail 10mmX34cm 125 L 47-2493-305-11 ZNN CMN Nail 11.5mmX30cm 135 L 47-2493-325-10 ZNN CMN Nail 10mmX32cm 135 L 47-2493-305-13 ZNN CMN Nail 13mmX30cm 135 L 47-2493-325-11 ZNN CMN Nail 11.5mmX32cm 135 L 47-2493-365-13 ZNN CMN Nail 13mmX36cm 135 L 47-2493-325-13 ZNN CMN Nail 13mmX32cm 135 L 47-2493-344-10 ZNN CMN Nail 10mmX34cm 135 R 47-2493-304-10 ZNN CMN Nail 10mmX30cm 135 R 47-2493-344-11 ZNN CMN Nail 11.5mmX34cm 135 R 47-2493-304-11 ZNN CMN Nail 11.5mmX30cm 135 R 47-2493-344-13 ZNN CMN Nail 13mmX34cm 135 R 47-2493-304-13 ZNN CMN Nail 13mmX30cm 135 R 47-2493-364-10 ZNN CMN Nail 10mmX36cm 135 R 47-2493-324-10 ZNN CMN Nail 10mmX32cm 135 R 47-2493-364-11 ZNN CMN Nail 11.5mmX36cm 135 R 47-2493-324-11 ZNN CMN Nail 11.5mmX32cm 135 R 47-2493-364-13 ZNN CMN Nail 13mmX36cm 135 R 47-2493-324-13 ZNN CMN Nail 13mmX32cm 135 R 47-2493-385-10 ZNN CMN Nail 10mmX38cm 135 L 47-2493-345-10 ZNN CMN Nail 10mmX34cm 135 L 47-2493-385-11 ZNN CMN Nail 11.5mmX38cm 135 L 47-2493-345-11 ZNN CMN Nail 11.5mmX34cm 135 L 47-2493-385-13 ZNN CMN Nail 13mmX38cm 135 L 47-2493-345-13 ZNN CMN Nail 13mmX34cm 135 L 47-2493-384-10 ZNN CMN Nail 10mmX38cm 135 R 47-2493-365-10 ZNN CMN Nail 10mmX36cm 135 L 47-2493-384-11 ZNN CMN Nail 11.5mmX38cm 135 R 47-2493-365-11 ZNN CMN Nail 11.5mmX36cm 135 L 47-2493-384-13 ZNN CMN Nail 13mmX38cm 135 R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0119-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-14

Product code HSB

K091566Class IIZimmer Natural Nail System Cephalomedullary NailsZimmer GmbH / cleared 2009-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)