Implant Direct recalls Legacy 3 implants with incorrect cover screw that may delay surgery or require new procedures. Affected units have specific size and lot numbers.
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.
Implant Direct is recalling Legacy 3 implants that may have the wrong cover screw, which could delay surgery or require additional procedures. This affects patients undergoing specific implant surgeries.
The implant package contains an incorrect cover screw and extender. This could cause delays in surgery or require new procedures to place the correct parts. The severity depends on whether the surgery is one or two stages.
Patients who have received the Legacy 3 implant with size 5.7mmD x 10mmL and lot number 68209 are affected. Those undergoing one or two-stage surgeries are most at risk.
Check for the Legacy 3 implant with size 5.7mmD x 10mmL and lot number 68209. The product is labeled as RxOnly, Sterile R, and has the CE 0086 certification.
Verify the lot number on the implant package to confirm if it is affected (lot # 68209).
The recall was initiated after customer complaints and internal investigation found some implant packages contain the incorrect cover screw and extender.
The recall states it may delay surgery or require new procedures, but does not mention serious injury risks.
Check for the Legacy 3 implant with size 5.7mmD x 10mmL and lot number 68209 on the package label.
We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.
Subject: Recall Z-1157-2020 — Implant Direct Implant Direct Hello, I own a Implant Direct that is covered by recall Z-1157-2020 from Implant Direct. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
