Zimmer Dental Waxing Coping Recall Due to Missing Supplemental Instructions
Zimmer Biomet is recalling dental waxing copings because they were shipped with only standard instructions, missing required supplemental IFUs.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II but involves a documentation issue (missing supplemental IFUs) with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling/documentation errors.
Plain-English summary
Zimmer Biomet is conducting a medical device field correction for various dental products, specifically waxing copings, manufactured by Zimmer Dental Inc. The recall involves 423 products across multiple sizes and reference numbers, including ZOCWAX3A, ZOCWAX3S, ZOCWAX4A, ZOCWAX4S, ZOCWAX5A, ZOCWAX5S, ZOCWAX6A, and ZOCWAX6S.
The reason for this field correction is that several parts were shipped to customers with only standard Instructions for Use (IFUs). All affected products were missing the required supplemental IFUs. The products were distributed to the US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, and Korea (the Republic of).
This is a Class II recall. No specific illnesses or injuries are reported in the source text. Healthcare providers and distributors should verify their inventory against the provided lot numbers and contact Zimmer Biomet for further instructions regarding the missing documentation.
The recalled product
- Product
- WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COP
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Supplies
- Hazard
- Affected units
- 423
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Zimmer Dental Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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