Affixus Hip Fracture Nail, RH 130 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 130 DEG 9MM X 260MM, distributed nationwide in the United States as well as in Portugal and the Netherlands. During a rework process for a previous field action, the set screw and sleeve assembly—which are designed to fit together with an interference fit—were found to be no longer in their proper installed location on certain units.
This misalignment could prevent proper assembly of the product with the mating screw and targeting jig, potentially affecting the product's function. The affected units are identified by Item No. 814509260 with four specific lot numbers: 581640 (expiration 05/27/2027), 788410 (expiration 06/15/2027), 892940 (expiration 06/15/2027), and 892950 (expiration 06/15/2027). The source does not specify a remedy or what affected consumers should do.
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. 814509260; Lot No. (Exp. Date) UDI: 581640 (05/27/2027) UDI (01)00887868038853 (17)270527 (10)581640; 788410 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)788410; 892940 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)892940; 892950 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)892950
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.