FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing, LLC: Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
- Recall number
- Z-2125-2017
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Product
- Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
- Status
- Terminated
- Initiated
- 2017-05-02
- Posted
- not on file
- Terminated
- 2018-01-08
- Reason
- Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
- Root cause
- Nonconforming Material/Component
- Action
- Implant Direct sent an Urgent Medical Device Field Corrective recall letter dated April 2017 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed that the product may be out of Implant Direct specification. The abutment should have a full hex configuration from end of part to shoulder (1.6mm). When the part is in-correct there will be a noticeable diameter ring just above shoulder and a hex flat face that appears short (@ 1.1mm) not allowing full engagement to implant analog. This discrepancy may lead to the possibility of the abutment not seating properly on the implant, and if undetected may lead to micro-leakage and a possible infection to the patient. Customers are instructed to complete and return the Acknowledgement and Recall Return form within 48 hrs. Customers with any questions are instructed to contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
- Quantity
- 151 units
- Distribution
- Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
- Lot, serial or model codes
- 89103, 83493, 78986
- 510(k) numbers
- ["K061319"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3001617766
- Firm city
- Westlake Village
- 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