Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
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 9MM X 440MM) distributed nationwide in the US as well as in Portugal and the Netherlands. During a rework process for a previous field action, it was discovered that the set screw and sleeve assembly—which are designed to fit together tightly—were no longer in their correct installed location on some units.
This defect could prevent the product from assembling properly with the mating screw and targeting jig. The affected products are identified by Item No. 814609440 with Lot Nos. 507340 (expiring 05/22/2027) and 858900 (expiring 06/14/2027). The source document does not specify what remedy affected consumers should pursue.
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. 814609440; Lot No. (Exp. Date) UDI: 507340 (05/22/2027) UDI (01)00887868039744 (17)270522 (10)507340; 858900 (06/14/2027) UDI (01)00887868039744 (17)270614 (10)858900
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.