Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
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, LH 125 DEG 11MM X 440MM due to a manufacturing defect discovered during rework of a previous field action. The set screw and sleeve assembly, which should fit together with interference, were found to be missing from their installed location on affected units. This defect could prevent proper assembly of the product with the mating screw and targeting jig. The affected devices were distributed nationwide in the United States, as well as in Portugal and the Netherlands.
The recalled lot includes Item No. 814411440, Lot No. 459240, with an expiration date of May 21, 2027. The recalled devices are identified by UDI (01)00887868038525 (17)270521 (10)459240. The recall record does not specify a remedy or action that affected consumers should take.
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. 814411440; Lot No. 459240; Exp. Date 05/21/2027, UDI (01)00887868038525 (17)270521 (10)459240
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.