Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of its Affixus Hip Fracture Nail (125 DEG 11MM X 180MM) distributed nationwide in the United States, as well as in Portugal and the Netherlands. During a rework process related to an earlier April 17, 2017, field action, the set screw and sleeve assembly—which are designed to fit tightly together—were found to be missing from their installed location on some units. This missing component could prevent the product from assembling properly with the mating screw and targeting jig.
The affected product is identified by Item No. 814311180, Lot No. 459190, with an expiration date of May 17, 2027. The source document does not specify what remedy affected consumers should take regarding this recall.
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. 814311180, Lot No. 459190, Exp. Date 05/17/2027, (01)00887868038082 (17)270517 (10)459190
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.