Zimmer Dental Recalls Abutment and Coping Products for Missing Instructions
Zimmer Biomet is correcting dental abutments and copings because they were shipped with standard instructions but missing supplemental instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for missing documentation (supplemental IFUs) with no reported injuries or health hazards, fitting the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Zimmer Biomet is conducting a medical device field correction for various dental products, including Abut Gold Friction-Fit and Coping Gold products. The recall involves 13,235 units of these dental components.
The reason for the field correction is that several parts were shipped to customers with only standard Instructions for Use (IFUs). All affected products were missing supplemental IFUs.
The products were distributed in 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). Consumers and dental professionals should contact Zimmer Dental Inc for further information regarding the missing documentation.
The recalled product
- Product
- ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 13,235
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- lot # 63196608
- 63224322
- 63260962
- 63327428
- 63327427
- 63346417
- 63355661
- 63355664
- 63355665
- 63376660
- 63376662
- 63376661
- 63376663
- 63395410
- 63395405
- 63395406
- 63395407
- 63395404
- 63406219
- 63406221
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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