Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM (Item No. 814311380, Lot No. 459200, expiring 05/18/2027) due to a defect discovered during rework of a previous field action. The set screw and sleeve assembly, which should fit together with an interference fit, were found to be missing from their installed location on some units. This defect could prevent proper assembly of the product with the mating screw and targeting jig.
The affected products were distributed nationwide in the United States as well as in Portugal and the Netherlands. The source document does not specify a remedy or instructions for consumers regarding what action should be taken.
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. 814311380; Lot No. (Exp. Date) UDI: 459200 (05/18/2027) UDI (01)00887868038150 (17)270518 (10)459200
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.