Affixus Hip Fracture Nail, LH 125 DEG 9MM 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 (LH 125 DEG 9MM X 380MM) distributed across the United States, Portugal, and the Netherlands. During rework of an earlier April 17, 2017 field action, the manufacturer discovered that the set screw and sleeve assembly—which should be tightly fitted together—had become dislodged from their proper location. This dislocation could interfere with proper assembly of the product with the mating screw and targeting jig.
The affected units are identified by Item No. 814409380, with two specific lot numbers: UDI 398590 (expiration date 05/19/2027) and UDI 702190 (expiration date 06/04/2027). The source document 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. 814409380; Lot No. (Exp. Date) UDI: 398590 (05/19/2027 UDI (01)00887868038389 (17)270519 (10)398590; 702190 (06/04/2027) UDI (01)00887868038389 (17)270604 (10)702190
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.