FDA Device recall Z-1914-2017
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, 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, 10 MM X 3 INCH, REF 71369210, 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-1914-2017 |
| 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, 10 MM X 3 INCH, REF 71369210, 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: 472439,472579,472580,477931,482918,493639,11150707,4357136921,4500027315,4500030673, 4500032565,07AM…Batch numbers: 472439,472579,472580,477931,482918,493639,11150707,4357136921,4500027315,4500030673, 4500032565,07AM06944,07LSY0047,07LSY0048,08BSY0012,08BSY0014B,08BSY0016, 08FSY0051,08JSY0012,08JSY0033,08KSY0015,08KSY0018,08LSY0011,08LSY0044,08LSY0044A, 08MSY0018,09BSY0011,09BSY0025,09DSY0012,09DSY0014,09FSY0005,09HSY0002,09HSY0006, 09HSY0006A,09JSY0002,09JSY0005,09JSY0006,09JSY0007,09JSY0008,09JSY0009,09KSY0002, 10CSY0003,10CSY0013,10CSY0014,10ESY0012,10ESY0017,10GSY0006,10HSY0007,10MSY0007, 11ASY0004,11ASY0008,11CSY0014,11DSY0002,11DSY0012,11ESY0006,11FSY0003,11FSY0004, 11GSY0002,11GSY0019,11GSY0020,11HSY0016,11HSY0023,12CSY0004,12DSY0024,12DSY0027, 12FSY0025,12HSY0006,12HSY0021,12HSY0035,12KSY0021,12LSY0017,12MSY0003,12MSY0011, 13BSY0006,13BSY0012,13BSY0038,13BSY0039,13ESY0006,13FSY0016,13HSY0003,13HSY0006, 13HSY0007,13KSY0047,13MSY0002,14ASY0033,14BSY0011,14CSY0004,14CSY0033,14DSY0013, 14DSY0015,14GSY0018,14HSY0005,14HSY0011,14KSY0002,14LSY0009,15ASY0013,15BSY0008, |
|---|
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-1914-2017%22
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