Z-2233-2018 Class II Terminated
FDA device recall Z-2233-2018 was initiated by Zimmer Biomet, Inc. on May 16, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 5, 2024). Affected quantity: 1234.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 27, 2018
- Initiation Date
- May 16, 2018
- Termination Date
- Apr 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1234
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.
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.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2233-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026