FDA Device recall Z-3204-2017
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
- FDA Device
- Class II
- terminated
- Published 2017-10-04
On 2017-10-04 the FDA classified a Class II recall of Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223 by Zimmer Dental, citing zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the produ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3204-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-10 |
| Published | 2017-10-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Dental |
| Distribution | n/a |
Product
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Reason
Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Identifiers
| code_info | lot # 63062148, 63386541, 0300481, 63386544, 63536617, 63426541, 3460410, 63426542, 63503028 |
|---|
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-3204-2017%22
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