Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1064-2018)

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:

6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial plateau fractures, SI joint disruptions, Intercondylar femur fractures, Subtalar arthrodesis, and Fixation of pelvis and iliosacral joint.

Product Classification:

Class II

Date Initiated: December 7, 2017
Date Posted: March 21, 2018
Recall Number: Z-1064-2018
Event ID: 79387
Reason for Recall:

One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

Status: Terminated
Product Quantity: 6
Code Information:

Lot: 120910

Distribution Pattern:

Canada.

Voluntary or Mandated:

Voluntary: Firm initiated