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SwishTapered Implant recallZ-1112-2017 · Implant Direct Sybron Manufacturing, LLC · initiated Dec 12, 2016

Class II Terminated All recalls posted in January 2017

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

The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

FDA root cause category: Packaging process control

What the company is doing

Customer notification letters were sent on 12/12/16. Customers were requested to review inventory for the affected product. Complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized distributor the firm requests that they identify those customers that may have been shipped the affected product lot and contact those customers to inform them of the issue within 48 hours of receipt of the notification in order to provide the customers with replacement product. If customers have any of the affected product the firm will send a replacement part. Any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.

Recall details

Recall number
Z-1112-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 12, 2016
Posted by the FDA
Jan 28, 2017
Recalling firm
Implant Direct Sybron Manufacturing, LLC
Quantity
17
Product code
DZE
FDA submissions
K090234
Distribution
U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.

Product description

SwishTapered Implant

Code information (models, lots, serial numbers)

933308 Lot # 73241

Other devices under the same FDA submission

123 devices cleared under K090234 — 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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