Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet recalled 638 units of Affixus Hip Fracture Nail (Item No. 814309420, Lot No. 935970, expiration date 06/15/2027) distributed nationwide in the US, Portugal, and the Netherlands. During a rework process for a previous field action dated April 17, 2017, the set screw and sleeve assembly—which are designed to fit together tightly—were found to have shifted out of their proper installed location.
This misalignment could prevent the product from assembling correctly with the mating screw and targeting jig, potentially compromising the device's functionality. The recall record does not specify a remedy or any actions affected consumers should take.
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. 814309420; Lot No. (Exp. Date) UDI: 935970 (06/15/2027) UDI (01)00887868038051 (17)270615 (10)935970
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.