Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2233-2018)

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:

BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 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-2233-2018

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: 1234

Code Information:

410640 410650 413650 561810 700980 828080 843730 244860 579030 265412 276373 562990 754210 235170 546830 579480 929310 013900 958060 560420 560450 C32280 C32290 E36750 056530 241100 089550 528280 015770 564990 643870 067590 822470 822480 670840 038710 391720 380280 558070 016760 174930 695650 399280 932230 963110

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