Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM due to a manufacturing defect discovered during a rework process. The set screw and sleeve assembly, which should fit snugly together, became dislodged from their proper location, potentially preventing the nail from assembling correctly with the mating screw and targeting jig. The affected products were distributed nationwide in the United States as well as in Portugal and the Netherlands.
The recalled units include two lot numbers: Item No. 814609320 with expiration date 05/24/2027 and Item No. 942050 with 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. 814609320; Lot No. (Exp. Date) UDI: 535150 (05/24/2027) UDI (01)00887868039683 (17)270524 (10)535150; 942050 (06/15/2027) UDI (01)00887868039683 (17)270615 (10)942050
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.