Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM
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 130 DEG 9MM X 420MM) distributed nationwide in the US as well as in Portugal and the Netherlands. During rework of a previous April 17, 2017 field action, the set screw and sleeve assembly—which should fit tightly together—was found to be loose or missing from its proper location. This defect could prevent the nail from assembling correctly with the mating screw and targeting jig, potentially compromising the product's function during use.
The affected product is identified by Item No. 814609420 with two lot numbers: UDI 438040 (expiration 05/22/2027) and UDI 701640 (expiration 06/04/2027). 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. 814609420; Lot No. (Exp. Date) UDI: 438040 (05/22/2027) UDI (01)00887868039737 (17)270522 (10)438040; 701640 (06/04/2027) UDI (01)00887868039737 (17)270604 (10)701640
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.