Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. recalled 638 units of Affixus Hip Fracture Nail (Item No. 814611340, Lot No. 535240, expiration date 05/24/2027) distributed nationwide in the US, Portugal, and the Netherlands. During a rework process for a previous field action, the set screw and sleeve assembly—which are designed to fit tightly together—was found to have moved from its proper location on some units.
This displacement could prevent the product from assembling correctly with the mating screw and targeting jig, potentially affecting its function. The source document does not specify what action affected 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. 814611340; Lot No. (Exp. Date) UDI: 535240 (05/24/2027) UDI (01)00887868039805 (17)270524 (10)535240
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.