Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM
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 125 DEG 9MM X 260MM due to a defect discovered during a rework process. The set screw and sleeve assembly, which should be tightly fitted together, were found to be missing from their installed location on some units. This defect could prevent the product from assembling properly with the mating screw and targeting jig, potentially compromising the device's function.
The affected devices were distributed nationwide in the United States as well as in Portugal and the Netherlands. They are identified by item number 814409260, lot number 936020, with an expiration date of June 15, 2027. The recall notice does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
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. 814409260; Lot No. 936020; Exp. Date 06/15/2027, UDI (01)00887868038327 (17)270615 (10)936020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.