Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2241-2018)

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:

RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Product Classification:

Class II

Date Initiated: May 16, 2018

Date Posted: June 27, 2018

Recall Number: Z-2241-2018

Event ID: 80193

Reason for Recall:

The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

Status: Terminated

Product Quantity: 248

Code Information:

001360 008170 106320 330040 952200 924770 446470 446480 337720 032750 971520 957780 295550

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated