FDA Medical Device Recalls (openFDA)
Keystone Dental Inc: Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
- Recall number
- Z-1818-2017
- Recalling firm
- Keystone Dental Inc
- Product
- Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
- Status
- Terminated
- Initiated
- 2017-03-09
- Posted
- 2017-04-13
- Terminated
- 2017-07-05
- Reason
- Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
- Root cause
- Labeling mix-ups
- Action
- Keystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272
- Quantity
- 59 units
- Distribution
- CA, IL, IN, FL, MA, MN, NJ, NV, PA,
- Lot, serial or model codes
- Lot Number: 30214
- 510(k) numbers
- ["K051614"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3005990499
- Firm city
- Burlington
- Firm state
- MA
- 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