Trigen Intertan
510(k) K040212
Trigen Intertan is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K040212 on 20 Feb 2004, active as of 22 Oct 2026. 6 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040212 | Date20 Feb 2004 | StatusActive |
Official records
- FDA 510(k) database K040212
Recalls
-
- Ongoing Z-1133-2022
Right nails were anodized, marked, and labelled as left nails and vice versa
-
- Ongoing Z-0097-2018
A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
-
- Terminated Z-0772-2021
Manufacturing packaging error.
-
- Terminated Z-2258-2014
There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.
-
- Terminated Z-1636-2014
- Terminated Z-1637-2014
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Timeline
- Cleared FDA 510(k) K040212
- Recall initiated FDA recalls Z-1636-2014
- Recall initiated FDA recalls Z-1637-2014
- Recall initiated FDA recalls Z-2258-2014
- Recall initiated FDA recalls Z-0097-2018
- Recall initiated FDA recalls Z-0772-2021
- Recall initiated FDA recalls Z-1133-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JDS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent