Affixus Hip Fracture Nail, LH 130 DEG 9MM 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 9MM X 400MM due to a defect discovered during a rework process for a previous field action. The problem involves the set screw and sleeve assembly, which is designed to fit tightly in place but was found to be no longer installed in the correct location on affected units. This defect could prevent the product from assembling properly with the mating screw and targeting jig.
The affected devices were distributed nationwide in the United States as well as in Portugal and the Netherlands. The recalled units are identified by Item No. 814609400 and include three lot numbers with expiration dates of May 19, 2027, June 3, 2027, and June 14, 2027, each with specific UDI codes. The source document does not specify a remedy or 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. 814609400; Lot No. (Exp. Date) UDI: 480330 (05/19/2027) UDI (01)00887868039720 (17)270519 (10)480330; 701940 (06/03/2027) UDI (01)00887868039720 (17)270603 (10)701940; 858970 (06/14/2027) UDI (01)00887868039720 (17)270614 (10)858970
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.