Reported Sep 12, 2018 · Terminated
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner…
Zimmer Dental Inc.
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: Zimmer Dental Inc · 1900 Aston Ave · Carlsbad, CA · 92008-7308
Is this the product you have?
- Outer Package Label
Tapered Screw-Vent Implant System4.1mm X 10mm3.5mm
- REFTSVM4B10
- SterileR, Rx Only
- Inner Package LabelImplant, MTX, 3.7mm x 10mm,3.5mm
- REFTSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load
- Lot codes and dates
- Outer Package LabelLOT: 63781164
- UDI(01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164
- Inner Package LabelLOT: 63773888
- UDI(01) 00889024019508 (17) 220930 (10)63773888
- Amount recalled
- 299 units
Where it was sold
Why it was recalled
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
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 Zimmer Dental Inc. 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.