Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM due to a manufacturing defect discovered during rework of a previous field action. The set screw and sleeve assembly, which should be fitted together with an interference fit, were found to be no longer in their proper installed location on affected 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.
The affected units are identified by Item No. 814511420 with two specific lot numbers: lot UDI 535130 (expiration date 06/02/2027) and lot UDI 858960 (expiration date 06/15/2027). The source document 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. 814511420; Lot No. (Exp. Date) UDI: 535130 (06/02/2027) UDI (01)00887868039195 (17)270602 (10)535130; 858960 (06/15/2027) UDI (01)00887868039195 (17)270615 (10)858960
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.