GUIDE WIRE 2 — Class II medical device recall Z-0529-2020
Terminated recall by Zimmer Biomet, Inc., reported 2019-12-04, distributed nationwide. Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
| Recall number | Z-0529-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2019-08-21 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2021-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CO, CR, EC, IN, IT, JP, KR, MX, MY, NL, NZ, PA, SG, SV, TH, TT, TW, VE |
| Quantity | 2,468 |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00887868034664 |
| Lot numbers | 036360, 036370, 036380, 036390, 036400, 036410, 036420, 036430, 036440, 036450, 036460, 069570, 069980, 070100, 108350, 108380, 108390, 108400, 108410, 108430, 108450, 121498, 161370, 166860, 166870, 166870R, 212067, 233870, 233900, 270142, 270144, 270146, 270149, 270151, 270153, 323740, 323770, 323840, 323870, 323890 and 102 more |
| Model numbers | 809222028 |
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 for recall
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0529-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.