Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2236-2018)

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:

G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 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-2236-2018

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: 361

Code Information:

554260 595180 700960 828070 845960 244870 002630 086190 298890 754200 342500 384400 662420 934740 643860 547310 977760 469890 399260

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