Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet recalled 638 units of the Affixus Hip Fracture Nail (model RH 130 DEG 9MM X 340MM) distributed nationwide in the US, Portugal, and the Netherlands. During rework for a prior field action initiated on April 17, 2017, the set screw and sleeve assembly—which should fit tightly together—were found to have shifted from their proper location. This misalignment could prevent the product from assembling correctly with the mating screw and targeting jig.
The affected units are identified by item number 814509340 with two lot numbers: UDI 535120 (expiration 05/24/2027) and UDI 893500 (expiration 06/12/2027). The source document does not specify a remedy or corrective action 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. 814509340; Lot No. (Exp. Date) UDI: 535120 (05/24/2027) UDI (01)00887868038891 (17)270524 (10)535120; 893500 (06/12/2027) UDI (01)00887868038891 (17)270612 (10)893500
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.