FDA Device recall Z-1909-2017
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
- FDA Device
- Class II
- terminated
- Published 2017-05-10
On 2017-05-10 the FDA classified a Class II recall of RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1) by Smith And Nephew, citing the stability data does not support the product labeled with a 10-year shelf life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1909-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-30 |
| Published | 2017-05-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
Reason
The stability data does not support the product labeled with a 10-year shelf life.
Identifiers
| code_info | Batch numbers: 431604,442526,448956,463451,469005,473044,477931,481940,488987,493639,494049,494154, 4357136931,4500…Batch numbers: 431604,442526,448956,463451,469005,473044,477931,481940,488987,493639,494049,494154, 4357136931,4500034104,07MSY0014,08CSY0043,08CSY0050,08CSY0053,08CSY0053B,08JSY0007, 08LSY0012,08MSY0016,10CSY0006,10HSY0006,11DSY0003,11ESY0007,11FSY0008,11GSY0009, 11GSY0025,11JSY0010,11MSY0020,12ASY0012,12BSY0017,12CSY0006,12HSY0008,12HSY0038, 12KSY0029,12LSY0024,12MSY0024,13BSY0030,13BSY0031,13FSY0018,13FSY0020,13LSY0010, 13MSY0004,14ASY0002,14CSY0007,14CSY0036,14GSY0026,14LSY0011,15ASY0015,15DSY0013, 15FSY0015,15KSY0037,16ASY0007,16BSY0014,16GSY0022,463451A,469005B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1909-2017%22
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