Reported Oct 4, 2017 · Terminated
WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG,…
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?
8 of 8 products
| Model / number | Product as published |
|---|---|
ZOCWAX3A | WAXING COPING, CONT 3.5 MM,ANG |
ZOCWAX3S | WAXING COPING, CONT 3.5 MM |
ZOCWAX4A | WAXING COPING, CONT 4.5MM, ANG |
ZOCWAX4S | WAXING COPING, CONT 4.5MM |
ZOCWAX5A | WAXING COPING, CONT, 5.5MM,ANG |
ZOCWAX5S | WAXING COPING, CONT, 5.5MM |
ZOCWAX6A | WAXING COPING, CONT, 6.5MM,ANG |
ZOCWAX6S | WAXING COPING, CONT, 6.5MM |
- Lot codes and dates
- lot #
6262516763254074634556226315500863331292634324956315207063209557632540476260247063135399632402396325402361722820625931866263542063254006
- lot #
- Amount recalled
- 423 products
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
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.
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