FDA Device recall Z-0529-2020
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilit…
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilit… by Zimmer Biomet, citing elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0529-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-21 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Reason
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Identifiers
| code_info | Lots: 323740 323770 323870 323970 324050 957830 957880 323840 323890 323910 323930 957800 987260 987480…Lots: 323740 323770 323870 323970 324050 957830 957880 323840 323890 323910 323930 957800 987260 987480 987720 485140 486100 485470 485850 069570 069980 070100 977580 977670 977690 977700 977710 977720 977730 977750 661460 661440 661450 161370 166860 166870 166870R 108410 108350 108380 108390 108400 108430 108450 472150 392630 392650 392660 392680 233870 233900 471850 471860 471870 472140 472160 036430 036390 036370 036360 036400 036450 036380 036410 036420 036440 036460 121498 212067 270142 270144 270146 270149 270151 270153 A3WAA7 A3WAB7 A3WAC7 A4WAA7 A4WAC7 A4WAD7 AD4AB7000 ADJAB7000 AP8AC7 AP8AD7000 B3TAH7 BA8AA7 BY3AB7 C25AA7 C25AB7 C4YAA7 CA3AA7 CD8AA7 CW3AA7 CW3AB7 CW3AC7 D38AC7 D3CAC7 D3CAF7 D4EAD7 D4EADA D5VAJ7 D66AD7 DF9AA7 DH6AA7 DH6AA7R DN5AJ7 DV3AA7 DW7AA7 DW7AAA E2PAD7 E2PAE7 E2PAG7 E2YAD7 E36AC7 E45AD7 E4EAB7 E55AD7 E55AE7 E5CAB7 E5CAC7 E5VAJ7 EG9A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0529-2020%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.