Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM
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 130 DEG 13MM X 280MM) distributed nationwide in the US, Portugal, and the Netherlands. During a rework process for a prior field action, the set screw and sleeve assembly—which should fit together with interference—were found to have shifted from their installed location. This misalignment could prevent proper assembly with the mating screw and targeting jig.
The affected units are identified by Item No. 814513280 in two lots: Lot No. 581960 (expiration 05/31/2027) and Lot No. 858740 (expiration 06/26/2027), with corresponding UDI codes provided. The source does not specify a remedy or course of action 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. 814513280; Lot No. (Exp. Date) UDI: 581960 (05/31/2027) UDI (01)00887868039263 (17)270531 (10)581960; 858740 (06/26/2027) UDI (01)00887868039263 (17)270626 (10)858740
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.