Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM
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, RH 130 DEG 13MM X 300MM due to a defect discovered during rework of a previous field action. The set screw and sleeve assembly, which should be fitted together with an interference fit, were found to be missing from their installed location in some 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 devices are identified by item number 814513300 and include two lot numbers with expiration dates of 06/01/2027 and 06/24/2027, along with their corresponding UDI (Unique Device Identifier) codes. The source document does not specify a remedy or any action for affected consumers to 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. 814513300; Lot No. (Exp. Date) UDI: 581970 (06/01/2027) UDI (01)00887868039270 (17)270601 (10)581970; 942010 (06/24/2027) UDI (01)00887868039270 (17)270624 (10)942010
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.