Zimmer Natural Nail CM Long. Intramedullary Fixation recall
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization…
Why was Zimmer Natural Nail CM Long. Intramedullary Fixation recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization…
- Recalling firm
- Zimmer Gmbh
- Quantity
- 57,603 units
- Distribution
- US Nationwide distribution.
- Recall date
- October 21, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)