Reported May 30, 2018 · Terminated
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part…
Implant Direct Sybron Manufacturing, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Implant Direct Sybron Manufacturing, LLC · 3050 E Hillcrest Dr · Westlake Village, CA · 91362-3171
Is this the product you have?
- ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
- Lot codes and dates
- Lot #71729
- Amount recalled
- 18 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Implant Direct Sybron Manufacturing, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.