Home › Ascension Orthopedics, Inc. › Integra® Total Foot System
Integra® Total Foot System
Ascension Orthopedics, Inc. · Model 2832106 · UDI-DI 10381780119227
2
510(k) clearances
59,207
Adverse events (76 deaths)
389
Recalls
656
Facilities
Description
The Integra Total Foot System open wedge plate is used for fixation for a variety of proximal metatarsal osteotomies. The stem is deepened and tapered for distraction of osteotomy during insertion and solid contact against cortical bone. It contains distal screw holes that are narrowed for an anatomic fit along the distal metatarsal and stems moved proximally on plate to minimize potential interference with proximal joint
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-09 | In2bones USA, LLC | Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws. |
| 2026-04-24 | Medartis AG | The cannulation of the CCS screw is not centered. |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2025-11-24 | Smith & Nephew, Inc. | Removal of affected lot of screws due to labeling error. |
| 2024-04-12 | Medartis Inc. | Screw is 16mm long instead of 22mm long. |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.