Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM across the United States, Portugal, and the Netherlands. During a rework process related to a previous April 17, 2017 field action, it was discovered that the set screw and sleeve assembly were no longer properly installed in their intended location, even though these components are designed to fit tightly together.
This defect could prevent the product from assembling correctly with the mating screw and targeting jig, potentially compromising its function. The affected units are identified by Item No. 814409340 with two lot numbers: UDI 581630 (expiring 06/03/2027) and UDI 942020 (expiring 06/16/2027). The source document does not specify a remedy 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. 814409340; Lot No. (Exp. Date) UDI: 581630 (06/03/2027 UDI (01)00887868038365 (17)270603 (10)581630; 942020 (06/16/2027) UDI (01)00887868038365 (17)270616 (10)942020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.