Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM due to a manufacturing defect discovered during a rework process. The set screw and sleeve assembly, which are designed to fit together with an interference fit, were found to be missing from their installed location on affected units. This defect could prevent the product assembly from working properly with the mating screw and targeting jig.
The recalled products were distributed nationwide in the United States as well as in Portugal and the Netherlands. The affected units are identified by Item No. 814309460 and Lot No. 737630 with an expiration date of 06/14/2027. The source document does not specify what remedy consumers should pursue regarding this recall.
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. 814309460; Lot No. (Exp. Date) UDI: 737630 (06/14/2027) UDI (01)00887868038075 (17)270614 (10)737630
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.