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IVA
DIOMEDICAL CO.,LTD. · Model A · UDI-DI 08809489298364
1
510(k) clearances
1,117
Adverse events (3 deaths)
11
Recalls
344
Facilities
Description
TLIF DISTRACTOR L32 x W9 x H9
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2020-09-30 | XTANT Medical | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. |
| 2013-10-07 | RTI Surgical, Inc. | As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requ |
| 2013-02-05 | SpineNet | The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to |
| 2012-06-15 | Exactech, Inc. | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Inter |
| 2011-09-23 | Synthes USA (HQ), Inc. | LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK |
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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.