FDA Medical Device Recalls (openFDA)
Zimmer Dental Inc: TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
- Recall number
- Z-3207-2017
- Recalling firm
- Zimmer Dental Inc
- Product
- TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
- 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
- 76 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 # 63145351, 63202941, 60646055, 62353334, 63316134
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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