Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM
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 125 DEG 9MM X 340MM, Item No. 814309340, Lot No. 581620 with expiration date 05/26/2027). During rework of a previous field action, the set screw and sleeve assembly—which are designed to fit together with interference—were found to no longer be properly installed. This could prevent the product assembly from working correctly with the mating screw and targeting jig.
The affected devices were distributed nationwide in the United States as well as in Portugal and the Netherlands. The FDA's recall notice does not specify a remedy or recommended action for 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. 814309340; Lot No. (Exp. Date) UDI: 581620 (05/26/2027) UDI (01)00887868038013 (17)270526 (10)581620
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.