Affixus Hip Fracture Nail, 125 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, 125 DEG 9MM X 180MM due to a defect discovered during rework of an earlier field action. The set screw and sleeve assembly, which should have an interference fit, were found to be missing from their installed location, which could prevent proper assembly with the mating screw and targeting jig. The affected product has item number 814309180, lot number 459250, and an expiration date of May 27, 2027. The product was distributed nationwide in the United States as well as in Portugal and the Netherlands.
The recall applies specifically to the 638 units identified with the lot and code information above. The source document does not specify a remedy 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. 814309180, Lot No. 459250, Exp. Date 05/27/2027, UDI (01)00887868037962 (17)270527 (10)459250
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.