Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM
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 130 DEG 11MM X 360MM) distributed nationwide in the United States, as well as in Portugal and the Netherlands. During rework of an earlier field action from April 17, 2017, the set screw and sleeve assembly was found to have shifted from its proper installed location. This assembly is designed to fit snugly with other components, and its displacement could prevent proper assembly with the mating screw and targeting jig.
The affected product has item number 814511360 and lot number 555620, with an expiration date of May 24, 2027. The source document does not specify a remedy or instructions for what consumers should do regarding this recall.
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. 814511360; Lot No. (Exp. Date) UDI: 555620 (05/24/2027) UDI (01)00887868039164 (17)270524 (10)555620
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.