Z-2376-2018Class II

REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

Name: Z-2376-2018 REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-05-18
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-05-18 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 on 2018-05-18. FDA classified it as Class II and gives the reason as "Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2376-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-18
Posted: 2018-07-05
Terminated: 2020-07-13
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 60 units
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
Product codes and lots: Lot numbers: 45353, 66011, and 75850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2376-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2376-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05

Product code DZE

K061319Class IISpectra SystemImplant Direct, LLC / cleared 2006-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)