Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM
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 11MM X 300MM, distributed nationwide in the US as well as in Portugal and the Netherlands. During rework of an earlier field action from April 17, 2017, the set screw and sleeve assembly—which should be fitted together tightly—were found to have separated from their proper location. This separation could prevent the product from assembling correctly with the mating screw and targeting jig.
The affected units are identified by Item No. 81461130, with two lot numbers: Lot No. 406280 (expiration date 05/19/2027) and Lot No. 972900 (expiration date 06/16/2027), along with their corresponding UDI codes. The source does not specify a remedy or corrective action for affected consumers.
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. 81461130; Lot No. (Exp. Date) UDI: 406280 (05/19/2027) UDI (01)00887868039782 (17)270519 (10)406280; 972900 (06/16/2027) UDI (01)00887868039782 (17)270616 (10)972900
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.