FDAMay 15, 2020device
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Lack of pouch seal. Product is labelled as sterile.
What to do
FDA enforcement status: Terminated
Brands named
tedan surgical innovationstedantedan surgical
UPCs
00851797006450
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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