FDA Device recall Z-1915-2017
RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, 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, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, 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-1915-2017 |
| 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, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, 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: 07MSY0001,08CSY0035,08FSY0034,08FSY0035,08FSY0035A,08LSY0013,08MSY0017,09BSY0023, 09BSY0026,09BSY002…Batch numbers: 07MSY0001,08CSY0035,08FSY0034,08FSY0035,08FSY0035A,08LSY0013,08MSY0017,09BSY0023, 09BSY0026,09BSY0026A,09DSY0008,09FSY0006,09HSY0003,09HSY0007,09JSY0003,10CSY0004, 10CSY0015,10CSY0016,10DSY0002,10ESY0009,10ESY0015,10ESY0019,11CSY0009,11CSY0015, 11FSY0007,11GSY0003,11GSY0022,11GSY0023,11HSY0062,11JSY0003,11MSY0018,12ASY0010, 12BSY0012,12CSY0005,12DSY0022,12DSY0028,12FSY0027,12HSY0007,12HSY0036,12KSY0016, 12KSY0022,12LSY0018,12LSY0023,12MSY0012,13ASY0007,13BSY0040,13DSY0009,13DSY0017, 13ESY0008,13ESY0009,13HSY0004,14ASY0034,14CSY0005,14CSY0034,14DSY0016,14DSY0018, 14GSY0016,14KSY0030,14LSY0010,14MSY0012,15ASY0023,15DSY0005,15ESY0020,15FSY0019, 15HSY0011,15JSY0045,15KSY0022,15LSY0070,16ASY0002,16BSY0009,16DSY0022,16ESY0058, 16ESY0077,16JSY0006,3000084920,431604,4500025459,4500030972,4500032273,4500032565, 4500034104,452406,456888,472579,483297,485498 |
|---|
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-1915-2017%22
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