FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing LLC: ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform
- Recall number
- Z-0198-2022
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Product
- ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
- Status
- Open, Classified
- Initiated
- 2021-09-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- Packaged dental implant contains a different size then the size declared on the labeling.
- Root cause
- Packaging change control
- Action
- On October 11, 2021, Implant Direct issued an "Urgent: Medical Device Recall" Notice via. Mail . In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1. Please immediately examine, identify, and quarantine the affected product subject to recall (Table-1). 2. If located, immediately return the affected product with the pre-paid shipping label included with the notification letter to us according to the instructions on the attached form. Upon receipt of the returned product a credit will be issued accordingly. 3. Please complete, scan, and email the Acknowledgement Form within forty eight (48) hours of receipt of this notification, whether you have affected product or not, to legacy2implants@implantdirect.com 4. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request 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 forty eight (48) hours of receipt of this notification. 5. If you have any questions, contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. If you or your patients have experienced any issues as a result of the affected products noted in this communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm Implant Direct Sybron Manufacturing sincerely apologizes for the inconvenience this situation may cause. 6. For Questions Contact: Customer Service and Technical Support team Monday through Friday, 8:00 AM to 4:30 PM, Pacific Time Zone Tel: 888-649-6425 Email: legacy2implants@implantdirect.com
- Quantity
- 83 implants
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.
- Lot, serial or model codes
- lot # 166300 / UDI: 10841307101796
- 510(k) numbers
- ["K192221"]
- 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