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
Check against the official notice below — it lists the full affected range.
New Standard Device Inc. is recalling Metalogix Self-Drill Half-Pins, which are components of the Revolution External Fixation System used in orthopedic surgery. The recall affects 410 devices distributed across ten U.S. states: Arizona, Georgia, Illinois, Montana, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, Texas, and Virginia. The pins are being recalled because complaints were received indicating that the tip can break during surgery.
The affected devices include four part numbers (620030, 620040, 620060, and 620080) in various sizes, with specific lot numbers identified for each. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Reason for recall: Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. Distribution: U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None Quantity: 410 total devices Lot/code info: Part Number / DESCRIPTION / UDI-DI Code / Lot Numbers: 620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X, A17219CA 620040 / Self-Drill Half-Pin 5x40x215mm / 854641008204 / A29418Y, A17219CB 620060 / Self-Drill Half-Pin 5x60x215mm / 854641008211 / A29418Z, A17219CC 620080 / Self-Drill Half-Pin 5x80x215mm / 854641008228 / A29518A, A17219CD
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.