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SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part… recallZ-1126-2020 · Implant Direct Sybron Manufacturing LLC · initiated Jan 9, 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

Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.

FDA root cause category: Process control

What the company is doing

On 01/09/2019 the firm sent an "Urgent Field Safety Notices to all affected consignees via FedEx Overnight mail. The recall does not include any US consignees. In addition to informing consignees about the recall the notification asked customer to take the following actions: 1. Please review your inventory for the affected product. If so, 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 48 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 of the affected product listed above, please return the product and we will send you a replacement part. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 00800 4030 4030 during the hours of 8:00AM to 5:30PM ET Monday through Thursday and 8:00AM to 5PM ET on Friday. The appropriate Regulatory Agencies have been notified of this action.

Recall details

Recall number
Z-1126-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 9, 2019
Posted by the FDA
Feb 10, 2020
Recalling firm
Implant Direct Sybron Manufacturing LLC
Quantity
11 units
Product code
NHA
FDA submissions
K081396
Distribution
US: None OUS: Iceland, Sweden, Spain,

Product description

SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

Code information (models, lots, serial numbers)

Lot # 109038 No affected devices distributed within the US.

Other devices under the same FDA submission

33 devices cleared under K081396 — 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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