Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
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 300MM) distributed nationwide in the US as well as in Portugal and the Netherlands. During a rework process associated with a previous field action from April 17, 2017, the set screw and sleeve assembly were found to have shifted from their proper installed location. This component is designed to have an interference fit and work with the mating screw and targeting jig.
The defect could prevent proper product assembly with the mating screw and targeting jig. The affected product was distributed under item number 814609300 across three lots with expiration dates ranging from May 2027 to July 2027. The recall record does not specify a remedy or action that affected consumers should take.
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. 814609300; Lot No. (Exp. Date) UDI: 595480 (05/28/2027) UDI (01)00887868039676 (17)270528 (10)595480; 788380 (06/15/2027) UDI (01)00887868039676 (17)270615 (10)788380; 973000 (07/10/2027) UDI (01)00887868039676 (17)270710 (10)973000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.