Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 638 units of Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM (Item No. 814313320, Lot No. 788630 with expiration date 06/05/2027) distributed nationwide in the US as well as in Portugal and the Netherlands. During a rework process for a previous field action dated April 17, 2017, the set screw and sleeve assembly were found to have shifted from their intended installed location. These components are designed to fit together with an interference fit.
The displacement of the set screw and sleeve assembly could prevent proper assembly of the product with the mating screw and targeting jig. The recall notice does not specify a remedy or instructions 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. 814313320; Lot No. (Exp. Date) UDI: 788630 (06/05/2027) UDI (01)00887868038242 (17)270605 (10)788630
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.