REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
FDA Recall Z-2376-2018 · Posted None
Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2018-05-18
Date Terminated2020-07-13
Product Quantity60 units
Reason for Recall
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Firm 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.
Root Cause
Process control
Distribution Pattern
CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.