FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0119-2016
- 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.
- Status
- Terminated
- Initiated
- 2015-09-03
- Posted
- 2015-10-14
- Terminated
- 2016-03-15
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K091566"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3005233524
- Firm city
- Winterthur
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28