Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM
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 440MM (Item No. 814611440, Lot No. 858840, expiration date 06/14/2027) due to a manufacturing issue discovered during a rework process. The set screw and sleeve assembly, which are designed to fit together with an interference fit, were found to be no longer in their installed location on affected units. This defect could prevent proper assembly of the product with the mating screw and targeting jig.
The affected product was distributed nationwide in the United States as well as in Portugal and the Netherlands. The source document does not specify a remedy or corrective action that consumers should take.
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. 814611440; Lot No. (Exp. Date) UDI: 858840 (06/14/2027) UDI (01)00887868039850 (17)270614 (10)858840
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.