FDAFebruary 18, 2019device
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
What to do
FDA enforcement status: Terminated
Brands named
tedan surgical innovationstedantedan surgical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCMerkury Innovations Recalls Hot + Cool Heating and Cooling Fans Due to Risk of Serious Injury or Death from Fire Hazard2026-06-11
- CPSCArctic Zone Titan Pro Coolers Recalled Due to Risk of Serious Injury or Death from Choking Hazard; Imported by California Innovations and Sold at Costco2026-06-11
- FDARoast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced by: Produce Inno...2026-05-27
- FDABrand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV...2026-04-24
- FDASharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife2026-04-23
- FDAArvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E2026-04-23
- FDAArvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C2026-04-23
- FDADa Vinci ASSY, PSS, SP1098, Part Number: 3806012026-04-22
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