Trident 623-00-26I
Trident 623-00-26I is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K033716 on 10 Feb 2005 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613327039351), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07613327039351 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k) | NumberK033716 | Date10 Feb 2005 | StatusActive |
Official records
- AccessGUDID record 07613327039351
- FDA 510(k) database K033716
Across registries
- FDA 510(k) K033716 decided 10 Feb 2005 Active
- FDA GUDID UDI-DI 07613327039351 listed 24 Sep 2015 Listed
Recalls
-
- Terminated Z-2810-2015
it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
-
- Terminated Z-0909-2010
Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.
Timeline
- Cleared FDA 510(k) K033716
- Recall initiated FDA recalls Z-0909-2010
- Recall initiated FDA recalls Z-2810-2015
- Listed FDA GUDID 07613327039351
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trident
- Generic name
- Non-constrained polyethylene acetabular liner
- Model / Ref / Catalog
- 623-00-26I
- Primary DI / UDI-DI
- 07613327039351
- 510(k) Number
- FDA product code
- LWJ, LZO, MEH, JDI, LPH
- GMDN term
- Non-constrained polyethylene acetabular liner
- Device class
- Class II
- Regulation number
- 888.3360, 888.3353, 888.3350, 888.3358
- GUDID distribution status
- In Commercial Distribution
- Size
- Lumen/Inner Diameter — 26.0 Millimeter