Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0431-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM

Product Classification:

Class II

Date Initiated: August 7, 2017

Date Posted: February 7, 2018

Recall Number: Z-0431-2018

Event ID: 78763

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.

Status: Terminated

Product Quantity: 638 units

Code Information:

Item No. 814611260; Lot No. (Exp. Date) UDI: 507350 (05/21/2027 UDI (01)00887868039768 (17)270521 (10)507350; 701700 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701700; 701720 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701720; 701780 (06/05/2027) UDI (01)00887868039768 (17)270605 (10)701780

Distribution Pattern:

US nationwide distribution. Also Portugal and the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated