Recall Z-1126-2020— Implant Direct Sybron Manufacturing LLC

Name: FDA recall Z-1126-2020
Creator: U.S. Food and Drug Administration
Published: 2019-01-09

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing LLC, initiated 2019-01-09, terminated 2021-04-27. It names one FDA 510(k) clearance: K081396. Product: SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708. Reason: 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..

Recalling firm: Implant Direct Sybron Manufacturing LLC
Classification: Class II
Status: Terminated
Initiated: 2019-01-09
Terminated: 2021-04-27
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081396 — SWISSPLANT DENTAL IMPLANT SYSTEMImplant Direct, LLC·cleared 2009-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.