Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM (Item No. 814611420, Lot No. 535690, expiring 05/30/2027) 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 was found to no longer be in its proper installed location, where it is designed to fit tightly.
The misplaced set screw and sleeve assembly could prevent the product from assembling correctly with the mating screw and targeting jig. The source document does not specify a remedy or recommended action for 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. 814611420; Lot No. (Exp. Date) UDI: 535690 (05/30/2027) UDI (01)00887868039843 (17)270530 (10)535690
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.