Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM
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 13MM X 260MM, Item No. 814313260, Lot No. 760270 with expiration date 06/12/2027) distributed nationwide in the US, Portugal, and the Netherlands. During rework of a prior April 17, 2017 field action, the set screw and sleeve assembly—which are designed to fit together tightly—were found to no longer be in their proper installed location.
This misplacement could prevent the product from assembling correctly with the mating screw and targeting jig. The source document does not specify a remedy or recommended action 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. 814313260; Lot No. (Exp. Date) UDI: 760270 (06/12/2027) UDI (01)00887868038211 (17)270612 (10)760270
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.