FDA Medical Device Recalls (openFDA)
Zimmer Dental Inc: Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
- Recall number
- Z-3204-2017
- Recalling firm
- Zimmer Dental Inc
- Product
- Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
- Status
- Terminated
- Initiated
- 2017-07-10
- Posted
- not on file
- Terminated
- 2019-08-05
- 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.
- 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
- 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)
- Lot, serial or model codes
- lot # 63062148, 63386541, 0300481, 63386544, 63536617, 63426541, 3460410, 63426542, 63503028
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDP
- Firm FEI
- 1038806
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28