Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet recalled 638 units of Affixus Hip Fracture Nail (model RH 130 DEG 11MM X 280MM) distributed nationwide in the US, Portugal, and the Netherlands. During a rework process related to an earlier April 17, 2017 field action, the set screw and sleeve assembly—which should be held in place by an interference fit—was found to have shifted from its proper location in certain units. This misalignment could prevent the product from assembling correctly with the mating screw and targeting jig.
The affected product has lot numbers and UDI codes 893430 and 893490, both expiring June 15, 2027. According to the recall record, no remedy is specified 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. 814511280 ; Lot No. (Exp. Date) UDI: 893430 (06/15/2027) UDI (01)00887868039126 (17)270615 (10)893430; 893490 (06/15/2027) UDI (01)00887868039126 (17)270615 (10)893490
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.