FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing, LLC: REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- Recall number
- Z-2376-2018
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Product
- REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- Status
- Terminated
- Initiated
- 2018-05-18
- Posted
- not on file
- Terminated
- 2020-07-13
- Reason
- Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
- Root cause
- Process control
- Action
- On May 18, 2018, Implant Direct Sybron Manufacturing LLC issued URGENT MEDICAL DEVICE RECALL notices to their customers. Customers were advised to take the following action: 1. Inspect your inventory for the affected product. 2. Complete and return the Acknowledgement and Recall Return Form within 48 hours for Quarantine product and return products listed. 3. Please return the product and the firm will send you a replacement part. 4. Authorized Implant Direct Sybron Manufacturing distributors, the firm requests that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours. Customers with questions with questions may contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST.
- Quantity
- 60 units
- Distribution
- CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
- Lot, serial or model codes
- Lot numbers: 45353, 66011, and 75850
- 510(k) numbers
- ["K061319"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3001617766
- Firm city
- Thousand Oaks
- 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