FDA Device recall Z-1919-2017
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, 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, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, 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-1919-2017 |
| 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, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, 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: 431604,431612,456888,467087,469005,477931,483297,483890,485498,490565,492345,493639, 4500027315,4500…Batch numbers: 431604,431612,456888,467087,469005,477931,483297,483890,485498,490565,492345,493639, 4500027315,4500029102,4500030972,4500034104,07LSY0011,07LSY0035,07LSY0038,07LSY0040, 08GSY0007,08GSY0007A,08GSY0008,08MSY0015,09BSY0029,10CSY0011,10CSY0023, 10ESY0011,11DSY0006,11DSY0011,11ESY0010,11HSY0012,11HSY0061,11JSY0007,12BSY0015, 12DSY0018,12DSY0030,12FSY0003,12GSY0030,12HSY0028,12HSY0044,12LSY0022,12MSY0007, 12MSY0015,13BSY0010,13BSY0013,13BSY0018,13BSY0035,13KSY0015,13MSY0008,14ASY0035, 14CSY0009,14CSY0042,14KSY0033,14LSY0014,15BSY0011,15DSY0004,15ESY0014,15JSY0008, 16ASY0009,16BSY0016,16KSY0002,469005A |
|---|
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-1919-2017%22
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