FDA Device recall Z-1913-2017
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, 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, 8 MM X 3 INCH, REF 71369208, 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-1913-2017 |
| 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, 8 MM X 3 INCH, REF 71369208, 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: 07LSY0036,07LSY0039,08CSY0039,08CSY0041,08CSY0052,08CSY0056,08JSY0011,08JSY0014, 08KSY0012,08LSY000…Batch numbers: 07LSY0036,07LSY0039,08CSY0039,08CSY0041,08CSY0052,08CSY0056,08JSY0011,08JSY0014, 08KSY0012,08LSY0006,08LSY0048,08LSY0049,08MSY0019,09BSY0008,09BSY0009,09BSY0010, 09DSY0011,09DSY0013,09FSY0004,09HSY0001,09HSY0005.09JSY0001,10CSY0002 10CSY0012, 10ESY0007,10ESY0008,10ESY0020,10HSY0008,11ASY0005,11ASY0009,11BSY0005,11CSY0013, 11DSY0001,11ESY0005,11FSY0002,11GSY0001,11GSY0018,11GSY0021,11HSY0063,11JSY0002, 12ASY0016,12BSY0011,12CSY0003,12DSY0023,12DSY0026,12FSY0026,12HSY0005,12HSY0022, 12KSY0020,12LSY0016,12MSY0002,13ASY0008,13ASY0009,13BSY0005,13BSY0011,13BSY0037, 13ESY0010,13ESY0011, 13HSY0002,13HSY0005,13KSY0010,13KSY0046,13MSY0001,14BSY0014, 14CSY0003,14CSY0032,14DSY0014,14GSY0019,14HSY0004,14KSY0001,14LSY0008,15ASY0012, 15ASY0021,15CSY0005,15DSY0001,15ESY0012,15FSY0017,15FSY0060,15HSY0005,15JSY0046, 15KSY0035,15MSY0008,16ASY0001,16DSY0021,16ESY0057,16FSY0001,16GSY0021,431612, 448956,4500030972,4500031584,455856,461831,477931,482918,488987,490565,492345 |
|---|
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-1913-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.