FDA Device recall Z-1637-2014
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF…
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF… by Smith And Nephew, citing A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1637-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-04 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew |
| Distribution | n/a |
Product
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.
Reason
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Identifiers
| code_info | (1) REF 71676515, Lot Number 13LT36602 (2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 1…(1) REF 71676515, Lot Number 13LT36602 (2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 14AT38714 (3) REF 71676558, Lot Numbers: 13KT36282, 13MT37356, 13MT37664, 13MT37949, 14AT38187 (4) REF 71676561, Lot Numbers: 13LT36605, 13MT37358, 14AT38188 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1637-2014%22
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