Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet recalled 638 units of the Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM, distributed nationwide in the US as well as in Portugal and the Netherlands. During rework for a previous April 17, 2017 field action, it was discovered that the set screw and sleeve assembly—which are designed to have an interference fit—were no longer in their installed location on some units. This condition could prevent the product assembly from working properly with the mating screw and targeting jig.
The affected lot numbers are UDI 760030 (expiration 06/14/2027) and UDI 788620 (expiration 06/07/2027), with item number 814309440. The recall source does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Reason for recall: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig. Distribution: US nationwide distribution. Also Portugal and the Netherlands. Quantity: 638 units Lot/code info: Item No. 814309440; Lot No. (Exp. Date) UDI: 760030 (06/14/2027) UDI (01)00887868038068 (17)270614 (10)760030; 788620 (06/07/2027) UDI (01)00887868038068 (17)270607 (10)788620
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.