Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of its Affixus Hip Fracture Nail (LH 130 DEG 11MM X 460MM) due to a manufacturing issue discovered during rework of a previous field action. The set screw and sleeve assembly, which are meant to fit together with an interference fit, were found to be missing from their installed location in some units, which could prevent proper assembly with the mating screw and targeting jig. The affected product was distributed nationwide in the US as well as in Portugal and the Netherlands.
The recall involves two lot numbers: Item No. 814611460 with Lot No. UDI 555810 (expiration date 05/27/2027) and Lot No. UDI 788580 (expiration date 07/17/2027). The source document does not specify a remedy or instructions 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. 814611460; Lot No. (Exp. Date) UDI: 555810 (05/27/2027) UDI (01)00887868039867 (17)270527 (10)555810; 788580 (07/17/2027) UDI (01)00887868039867 (17)270717 (10)788580
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.