PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 19, 2020 Initiated: January 9, 2019 #Z-1126-2020

Product Description

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

Reason for Recall

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.

Details

Units Affected
11 units
Distribution
US: None OUS: Iceland, Sweden, Spain,
Location
Westlake Village, CA

Frequently Asked Questions

What product was recalled?
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708. Recalled by Implant Direct Sybron Manufacturing LLC. Units affected: 11 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1126-2020.