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RePlant Angled Abutment recallZ-2320-2016 · Implant Direct Sybron Manufacturing, LLC · initiated Jul 5, 2016

Class II Terminated All recalls posted in August 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Implant Direct Sybron Manufacturing, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Issue with design specification; oversized condition.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2320-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 5, 2016
Posted by the FDA
Aug 2, 2016
Recalling firm
Implant Direct Sybron Manufacturing, LLC
Quantity
205
Product code
DZE
FDA submissions
K061319
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 description

RePlant Angled Abutment Part Number 6050-52-60

Code information (models, lots, serial numbers)

Lot #50174, 39799, 49364

Other devices under the same FDA submission

110 devices cleared under K061319 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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