Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM due to a defect discovered during rework of a previous field action. The set screw and sleeve assembly, which should fit tightly together, were found to be missing from their proper location in some units. This defect could prevent the product from assembling correctly with the mating screw and targeting jig.
The recalled devices were distributed nationwide in the United States as well as in Portugal and the Netherlands. They are identified by Item No. 814411360, Lot No. 935900, with an expiration date of 06/15/2027. The source document does not specify what action 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. 814411360; Lot No. 935900; Exp. Date 06/15/2027, UDI (01)00887868038488 (17)270615 (10)935900
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.