Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
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 11MM X 400MM, distributed nationwide in the US as well as in Portugal and the Netherlands. During rework for a previous field action in April 2017, it was found that the set screw and sleeve assembly—which are designed to fit tightly together—were no longer in their proper installed location on some units.
This defect could prevent the product from assembling correctly with the mating screw and targeting jig. The affected units include two lot numbers: Item No. 814611400 with Lot No. UDI 582380 (expiration 05/29/2027) and Lot No. UDI 702230 (expiration 06/04/2027). The source document does not specify a remedy or instructions for 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. 814611400; Lot No. (Exp. Date) UDI: 582380 (05/29/2027) UDI (01)00887868039836 (17)270529 (10)582380; 702230 (06/04/2027) UDI (01)00887868039836 (17)270604 (10)702230
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.