Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
- Recall Initiated
- October 26, 2018
- Recall Number
- Z-0363-2020
- Quantity
- 53 implants
- Firm Location
- Westlake Village, CA
Reason for Recall
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Distribution
US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
Lot / Code Info
Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023
Root Cause
Packaging
Action Taken
On 10/25/2018, a "URGENT: MEDICAL DEVICE RECALL" letter was sent to consignees via FedEx Priority overnight. The notification stated the following: 1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement Form within 48 hours for the product listed above; Quarantine product and return product listed above. 3. 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 fortyeight (48) hours of receipt of this notification. 4.If you have any of the affected product listed above, please return the product and we will send you a replacement part. 5.If you have any questions contact Implant Direct Sybron LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 6. 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