FDA Device recall Z-1916-2017
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, 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, 20 MM X 3 INCH, REF 71369220, 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-1916-2017 |
| 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, 20 MM X 3 INCH, REF 71369220, 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: 07MSY0006,07MSY0011,07MSY0011A,08CSY0037,08CSY0042,08ESY0082,08FSY0037, 08FSY0037B,08FSY0037C,08JSY0…Batch numbers: 07MSY0006,07MSY0011,07MSY0011A,08CSY0037,08CSY0042,08ESY0082,08FSY0037, 08FSY0037B,08FSY0037C,08JSY0008,08LSY0014,09BSY0012,09JSY0010,09JSY0011,09JSY0012, 10CSY0005,10CSY0017,10CSY0018,10KSY0033,11GSY0004,11GSY0024,11JSY0009,11KSY0068, 11MSY0019,12ASY0011,12BSY0013,12DSY0015,12DSY0029,12FSY0006,12FSY0030,12HSY0023, 12HSY0037,12KSY0023,12LSY0019,12MSY0004,12MSY0018,13BSY0007,13BSY0014,13BSY0041, 13FSY0017,13FSY0019,13LSY0009,13LSY0011,13MSY0003,14ASY0001,14BSY0026,14CSY0035, 14GSY0017,14KSY0017,14LSY0012,15BSY0009,15ESY0009,15ESY0038,15FSY0053,15GSY0017, 15JSY0004,16ASY0003,16BSY0013,16ESY0076,431612,431614,433667,4500029102,4500034104, 455856,469005,472439,472439A,477931,483297,483890,491378,491378A,493639,494049,494154 |
|---|
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-1916-2017%22
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