Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet recalled 638 units of the Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM (Item No. 814411320) distributed nationwide in the US as well as in Portugal and the Netherlands. During rework of a previous field action from April 17, 2017, the set screw and sleeve assembly were found to be missing from their installed location on some units. This missing component could prevent proper assembly of the product with the mating screw and targeting jig.
The affected lot numbers include UDI 459230 (expiring 05/19/2027), UDI 701830 (expiring 06/03/2027), and UDI 893480 (expiring 06/12/2027). The source document does not specify a remedy or recommended 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. 814411320; Lot No. (Exp. Date) UDI: 459230 (05/19/2027) UDI (01)00887868038464 (17)270519 (10)459230, 701830 (06/03/2027) UDI (01)00887868038464 (17)270603 (10)701830, 893480 (06/12/2027) UDI (01) 00887868038464 (17)270612 (10)893480
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.