REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
This recall has been terminated (originally issued May 18, 2018).
- Recall Initiated
- May 18, 2018
- Terminated
- July 13, 2020
- Recall Number
- Z-2376-2018
- Quantity
- 60 units
- Firm Location
- Thousand Oaks, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
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 / Code Info
Lot numbers: 45353, 66011, and 75850
Root Cause
Process control
Action Taken
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.