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TeDan Surgical Innovations Recalls
13 recalls on record · September 26, 2012 to July 15, 2020 · Medical Devices
Recalls by year
12
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 15, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in
Hazard: Lack of pouch seal. Product is labelled as sterile.
July 15, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in
Hazard: Lack of pouch seal. Product is labelled as sterile.
July 15, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in
Hazard: Lack of pouch seal. Product is labelled as sterile.
July 15, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterio
Hazard: Lack of pouch seal. Product is labelled as sterile.
July 15, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterio
Hazard: Lack of pouch seal. Product is labelled as sterile.
July 15, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appro
Hazard: Lack of pouch seal. Product is labelled as sterile.
July 15, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appro
Hazard: Lack of pouch seal. Product is labelled as sterile.
May 13, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima
Hazard: There was incorrect raw material used in the production of the identified lot.
March 25, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trai
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.
March 25, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trai
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.
March 25, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start
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.
March 25, 2020Medical DevicesFDA
TeDan Surgical Innovations LLC recalls D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start
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.
September 26, 2012Medical DevicesFDA
Tedan Surgical Innovations Llc recalls Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Su
Hazard: This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.