New Standard Device

4 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

Class I - Dangerous

The threads on posts stripping out when tensioned during application process.

Jul 23, 2019 Other Medical Devices Nationwide View Details →

Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

Class I - Dangerous

Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

Dec 28, 2020 Other Medical Devices View Details →

Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

Class I - Dangerous

Due to manufacturing processing error, wrench causing stripping when torqueing nuts.

Aug 14, 2019 Other Medical Devices View Details →

1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

Class I - Dangerous

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.

Jun 8, 2020 Other Medical Devices Nationwide View Details →