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Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant… recallZ-1157-2020 · Implant Direct Sybron Manufacturing LLC · initiated Oct 11, 2019

Class II Terminated All recalls posted in February 2020

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

Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

FDA root cause category: Mixed-up of materials/components

What the company is doing

On October 11, 2019 the firm sent an "URGENT: MEDICAL DEVICE RECALL" letter via FedEx overnight priority mail. The letter advised the consignees of the recall. In addition, the letter states: We request that you take the following actions immediately:. 1. Please review your inventory for the affected product. If located, please quarantine the affected product and return the product to us according to the instructions on the attached form. 2. Please complete and return the Acknowledgement Form within fortyeight (48) hours of receipt of this notification, whether you have affected product or not. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request 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 of receipt of this notification. 4. If you have any questions 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. If you or your patients have experienced any issues as a result of the affected products noted in this URGENT: MEDICAL DEVICE RECALL HHE 855710 100419 Rev 01 Status: RELEASED printed 10/10/2019 2:27:23 PM by Jose Trejo www.implantdirect.com | 888-649-6425 communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm

Recall details

Recall number
Z-1157-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 11, 2019
Posted by the FDA
Feb 5, 2020
Recalling firm
Implant Direct Sybron Manufacturing LLC
Quantity
78 implants
Product code
DZE
FDA submissions
K090234
Distribution
US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO

Product description

Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,

Code information (models, lots, serial numbers)

Lot # 68209

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

How recalls are matched to devices · Editorial policy · Report an error on this page