FDASeptember 25, 2018device
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrect package labeling identifying the device
What to do
FDA enforcement status: Terminated
Brands named
dt medtech
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAHintermann Series Talar Implant, Left, Size 2 REF 3021122026-03-24
- FDAROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.2021-09-22
- FDAROSA One 3.1 Brain Application2020-01-06
- FDAROSA Brain 3.0 Application-Brain2020-01-06
- FDARosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or to...2019-09-10
- FDAClear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochlorid...2019-07-26
- FDAClear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); and b) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin...2019-07-26
- FDAClear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medtech Products Inc....2019-07-26
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