Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. recalled 638 units of the Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM due to a defect discovered during rework of a previous field action. The set screw and sleeve assembly, which should be held in place by an interference fit, were found to be missing from their installed location, which could prevent proper assembly of the product with the mating screw and targeting jig. The affected devices were distributed nationwide in the United States as well as in Portugal and the Netherlands, identified by specific lot numbers and expiration dates.
The recall affects units with Item No. 814344300 and lot numbers 459160 (expiring 05/18/2027) and 893470 (expiring 06/16/2027). The source document does not specify a remedy or corrective action for consumers who have received these devices.
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. 814344300; Lot No. (Exp. Date) UDI: 459160 (05/18/2027) UDI (01)00887868038112 (17)270518 (10)459160; 893470 (06/16/2027) UDI (01)00887868038112 (17)270616 (10)893470
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.