Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail (model RH 130 DEG 13MM X 440MM, Item No. 814513440, Lot No. 582240 with expiration date 05/27/2027) distributed nationwide in the US as well as in Portugal and the Netherlands. During a rework process related to an April 17, 2017 field action, the set screw and sleeve assembly—which should have an interference fit—was found to no longer be in its proper installed location on some units.
The displacement of the set screw and sleeve assembly could prevent the product from assembling correctly with the mating screw and targeting jig. The recall notice does not specify a remedy or corrective 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. 814513440; Lot No. (Exp. Date) UDI: 582240 (05/27/2027) UDI (01)00887868039348 (17)270527 (10)582240
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.