FDA Medical Device Recalls (openFDA)
Keystone Dental Inc: Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
- Recall number
- Z-2162-2018
- Recalling firm
- Keystone Dental Inc
- Product
- Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
- Status
- Terminated
- Initiated
- 2018-05-01
- Posted
- not on file
- Terminated
- 2018-09-14
- Reason
- The implants are mislabeled.
- Root cause
- Error in labeling
- Action
- The Firm sent an Urgent Medical Device Correction letter dated April 30, 2018. In this discrepancy, the 5 is missing from the implant length description. Please note this discrepancy is limited to the implant package label only. The patient chart labels are all correct. Keystone Dental has performed a thorough review and determined there are no health hazards associated with this issue. There is no issue with the product within the package and the product can be safely used without issue in accordance with the defined surgical protocols. There is no risk of confusion of product size. The diameter is correct. Prima Plus implants are only available in 11.5mm lengths. The catalogs, surgical protocols and manuals only define procedures and provide instrumentation for placing 11.5mm length implants. Additionally, the patient chart labels contained within the implant package are correct so that patient procedure history will be properly maintained. The issue is limited to the label on the outside of the product package only. The lot identified above is the only affected lot. No other lots are affected with this issue. The product referenced above can be used safely without issue and no further action is required. For further questions, please call (866) 902-9272.
- Quantity
- 72
- Distribution
- US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
- Lot, serial or model codes
- UDI: D76815737K0, Lot 37038
- 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