ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
- Recall Initiated
- September 23, 2021
- Recall Number
- Z-0198-2022
- Quantity
- 83 implants
- Firm Location
- Westlake Village, CA
Reason for Recall
Packaged dental implant contains a different size then the size declared on the labeling.
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 / Code Info
lot # 166300 / UDI: 10841307101796
Root Cause
Packaging change control
Action Taken
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