Z-3204-2017Class II

Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223

Name: Z-3204-2017 Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Creator: Zimmer Dental Inc
Published: 2017-07-10
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2017-07-10 / Terminated

FDA source

Zimmer Dental Inc began a recall of Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223 on 2017-07-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3204-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-10
Posted: 2017-09-22
Terminated: 2019-08-05
Recalling firm: ZimVie US Corp LLC
Product: Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Product code: NDP Accessories, Implant, Dental, Endosseous
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.
FDA root cause: Under Investigation by firm
Action: The affected customers are being provided instructions on how to obtain the supplemental IFUs for respective part numbers from appropriate E-labeling website along with a recall notice.
Quantity in commerce: 349 products
Distribution: US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
Product codes and lots: lot # 63062148, 63386541, 0300481, 63386544, 63536617, 63426541, 3460410, 63426542, 63503028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3204-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3204-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3205-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3206-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3207-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3208-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3209-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3210-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)