Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
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 125 DEG 9MM X 260MM) distributed nationwide in the United States as well as in Portugal and the Netherlands. During rework of an earlier April 17, 2017 field action, the set screw and sleeve assembly—which are designed to fit together with an interference fit—were found to have come loose from their installed location. This misalignment could prevent proper assembly of the product with the mating screw and targeting jig.
The recalled product includes lot number 702050 with an expiration date of 06/12/2027. The record does not specify a remedy or instructions for consumers who may have received or used this product.
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. 814309260; Lot No. (Exp. Date) UDI: 702050 (06/12/2027) UDI (01)00887868037979 (17)270612 (10)702050
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.