Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet recalled 638 units of the Affixus Hip Fracture Nail (Item No. 814511440, Lot No. 507320, expiration date 05/21/2027) distributed nationwide in the United States, Portugal, and the Netherlands. During rework of an earlier April 17, 2017 field action, the set screw and sleeve assembly—which should have an interference fit—was found to be missing from its installed location.
The missing component could prevent proper assembly of the product with the mating screw and targeting jig. The source does not specify a remedy or recommended action 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. 814511440; Lot No. (Exp. Date) UDI: 507320 (05/21/2027) UDI (01)00887868039201 (17)270521 (10)507320
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.