Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM
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 360MM) distributed nationwide in the US, Portugal, and the Netherlands. During rework of an earlier field action in April 2017, the set screw and sleeve assembly—which are designed to fit tightly together—were found to have shifted from their proper location in some units. This misalignment could prevent the nail from assembling correctly with the mating screw and targeting jig.
The affected products include Item No. 814309360 in two lot numbers: 788440 (expiration 06/15/2027) and 788460 (expiration 06/07/2027). 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. 814309360; Lot No. (Exp. Date) UDI: 788440 (06/15/2027) UDI (01)00887868038020 (17)270615 (10)788440; 788460 (06/07/2027) UDI (01)00887868038020 (17)270607 (10)788460
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.