Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM
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 125 DEG 9MM X 400MM, distributed nationwide in the United States as well as in Portugal and the Netherlands. During a rework process related to a prior April 17, 2017, field action, the set screw and sleeve assembly—which are designed to fit tightly together—were found to be missing from their installed location on some units.
The missing set screw and sleeve assembly could prevent the product from assembling properly with the mating screw and targeting jig. The affected products have item number 814309400 with lot numbers 437960 (expiring 05/20/2027) and 893070 (expiring 06/14/2027). The source document does not specify a remedy or recommended 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. 814309400; Lot No. (Exp. Date) UDI: 437960 (05/20/2027) UDI (01)00887868038044 (17)270520 (10)437960; 893070 (06/14/2027) UDI (01)00887868038044 (17)270614 (10)893070
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.