FDA Device recall Z-2234-2018
GUIDE WIRE w/ BALL TIP 2.0MMX98CM
- FDA Device
- Class II
- terminated
- Published 2018-06-27
On 2018-06-27 the FDA classified a Class II recall of GUIDE WIRE w/ BALL TIP 2.0MMX98CM by Zimmer Biomet, citing 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 fai….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2234-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-16 |
| Published | 2018-06-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 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
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.
Identifiers
| code_info | 228829 311230 311260 255105 152590 757210 982070 282057 283729 057650 292980 293094 299420 668040 579470 354970 519980 670820 695640 963100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2234-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.