Z-2320-2016Class II

RePlant Angled Abutment Part Number 6050-52-60

Name: Z-2320-2016 RePlant Angled Abutment Part Number 6050-52-60
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2016-07-05
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2016-07-05 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of RePlant Angled Abutment Part Number 6050-52-60 on 2016-07-05. FDA classified it as Class II and gives the reason as "Issue with design specification; oversized condition". 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-2320-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-05
Posted: 2016-08-02
Terminated: 2017-02-16
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: RePlant Angled Abutment Part Number 6050-52-60
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Issue with design specification; oversized condition.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Implant Direct sent an Urgent: Medical Device Field Corrective Action letter dated July 6, 2016, to all affected customers. The letter requests that it be reviewed and determined if customer has any affected product in inventory. Customers are asked to complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized Implant Direct Sybron Manufacturing distributor, they request that customers 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 the notification in order to provide the customers with the correct tool. If customers have any of the affected product listed the firm will send a replacement part. If any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Quantity in commerce: 205
Distribution: U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.
Product codes and lots: Lot #50174, 39799, 49364

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2320-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2320-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)