Home › GM DOS REIS INDUSTRIA E COMERCIO LTDA › EXPERT - Flexible Joint Fixation System
EXPERT - Flexible Joint Fixation System
GM DOS REIS INDUSTRIA E COMERCIO LTDA · Model EXPERT FAST - CORACOID PLATE · UDI-DI 07899258662268
HTN
Prescription
10
510(k) clearances
1,494
Adverse events (2 deaths)
4
Recalls
265
Facilities
Description
EXPERT FAST - CORACOID PLATE - Flexible Knotless Fixator Coracoid Plate with Inserter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-22 | TriMed Inc. | Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to b |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2016-08-12 | Arthrex, Inc. | The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. |
| 2013-10-03 | Synthes USA HQ, Inc. | During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. |
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.