Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM
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 130 DEG 11MM X 380MM (Item No. 814511360, Lot No. 862170, expiring 06/16/2027) distributed nationwide in the United States, Portugal, and the Netherlands. During a rework process related to a previous April 17, 2017 field action, the set screw and sleeve assembly was found to be missing from its installed location. The set screw and sleeve assembly are designed to fit together with an interference fit.
The missing set screw and sleeve assembly could prevent the product from assembling properly with the mating screw and targeting jig. The source document does not specify what actions affected 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. Quantity: 638 units Lot/code info: Item No. 814511360; Lot No. (Exp. Date) UDI: 862170 (06/16/2027) UDI (01)00887868039171 (17)270616 (10)862170
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.