Guide Sleeve 3 — Class II medical device recall Z-3204-2017
Terminated recall by Zimmer Dental Inc, reported 2017-10-04. Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts
| Recall number | Z-3204-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Dental Inc, Carlsbad, CA, United States |
| Recall initiated | 2017-07-10 |
| Classified | 2017-09-22 |
| Reported by FDA | 2017-10-04 |
| Terminated | 2019-08-05 |
| Countries outside the US | AE, AU, BE, CA, CL, CN, CO, CR, EC, FR, HK, IL, IT, JP, KR, LB, MA, MY, NL, PA, PK, RS, SA, SG, TH, TR, TT, TW, VE |
| Quantity | 349 products |
| Lot numbers | 0300481, 3460410, 63062148, 63386541, 63386544, 63426541, 63426542, 63503028, 63536617 |
| Model numbers | 2220, 2221, 2222, 2223 |
Product
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Reason for recall
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.
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-3204-2017. 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.