Medical DeviceJul 15, 2020
TeDan Surgical Innovations 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage recall — FDA Z-2524-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Recall history in this database
Classification mix: Class II: 12.
Medical DeviceJul 15, 2020
TeDan Surgical Innovations PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product recall — FDA Z-2526-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceJul 15, 2020
TeDan Surgical Innovations PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX recall — FDA Z-2528-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceJul 15, 2020
TeDan Surgical Innovations PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product recall — FDA Z-2527-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceJul 15, 2020
TeDan Surgical Innovations PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX recall — FDA Z-2530-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceJul 15, 2020
TeDan Surgical Innovations PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX recall — FDA Z-2529-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceJul 15, 2020
TeDan Surgical Innovations 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage recall — FDA Z-2525-2020
Lack of pouch seal. Product is labelled as sterile.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceMay 13, 2020
TeDan Surgical Innovations Fukushima suction tubes recall — FDA Z-1845-2020
There was incorrect raw material used in the production of the identified lot.
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceMar 25, 2020
TeDan Surgical Innovations D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product recall — FDA Z-1504-2020
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…
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceMar 25, 2020
TeDan Surgical Innovations DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE recall — FDA Z-1505-2020
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…
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceMar 25, 2020
TeDan Surgical Innovations D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product recall — FDA Z-1503-2020
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…
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceMar 25, 2020
TeDan Surgical Innovations DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE recall — FDA Z-1506-2020
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…
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies TeDan Surgical Innovations LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.