Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail (RH 130 DEG 11MM X 300MM) distributed nationwide in the US, Portugal, and the Netherlands. During a rework process related to an earlier field action from April 17, 2017, the set screw and sleeve assembly—which should fit together with an interference fit—were found to have moved from their proper installed location. This misalignment could prevent the product from assembling correctly with the mating screw and targeting jig.
The affected devices have lot numbers 480070, 858790, and 893450, with expiration dates ranging from June 12, 2027 to June 15, 2027. The recall source does not specify what remedy or corrective action 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. 814511300; Lot No. (Exp. Date) UDI: 480070 (06/12/2027) UDI (01)00887868039133 (17)270612 (10)480070; 858790 (06/12/2027) UDI (01)00887868039133 (17)270612 (10)858790; 893450 (06/15/2027) UDI (01)00887868039133 (17)270615 (10)893450
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.