Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling the Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM, due to a defect discovered during a rework process for a prior April 17, 2017 field action. The set screw and sleeve assembly, which are designed to fit together with an interference fit, were found to be no longer in their installed location in affected units. This defect could prevent the product from assembling properly with the mating screw and targeting jig.
The recalled product was distributed nationwide in the United States as well as in Portugal and the Netherlands. The recall affects specific lot numbers with expiration dates ranging from May 24, 2027 to June 15, 2027. Consumers or healthcare providers should identify affected units using the item number 814509360 and the associated lot and UDI codes provided. The source document does not specify what steps consumers should take 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. Lot/code info: Item No. 814509360; Lot No. (Exp. Date) UDI: 555460 (05/24/2027) UDI (01)00887868038907 (17)270524 (10)555460; 892960 (06/14/2027) UDI (01)00887868038907 (17)270614 (10)892960; 892990 (06/15/2027) UDI (01)00887868038907 (17)270615 (10)892990
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.