FDA Device recall Z-0097-2018
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
- FDA Device
- Class II
- ongoing
- Published 2017-11-22
On 2017-11-22 the FDA classified a Class II recall of smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL by Smith And Nephew, citing A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0097-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-10-24 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | CA, CT, IL, MO, TN |
Product
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
Reason
A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
Identifiers
| code_info | Lot number 16LM07111 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0097-2018%22
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