Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail (130 DEG 9MM X 180MM) distributed nationwide in the US, as well as in 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 with interference—were found to be missing from their installed location. This missing component could prevent the product from assembling properly with the mating screw and targeting jig.
The affected units are identified by Item No. 814509180, Lot No. 459290, with an expiration date of 05/17/2027. The record does not specify a remedy or instructions for what affected consumers should do.
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. 814509180, Lot No. 459290, Exp. Date 05/17/2027, (01)00887868038846 (17)270517 (10)459290
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.