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New Standard Device Recalls
4 recalls on record · June 15, 2022 to June 21, 2023 · Medical Devices
Recalls by year
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 21, 2023Medical DevicesFDA
New Standard Device Inc recalls 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100
Hazard: The threads on posts stripping out when tensioned during application process.
September 7, 2022Medical DevicesFDA
New Standard Device Inc recalls Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self
Hazard: Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
June 29, 2022Medical DevicesFDA
New Standard Device Inc recalls Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Hazard: Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
June 15, 2022Medical DevicesFDA
New Standard Device Inc recalls 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Hazard: 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.