Implant Direct Sybron Recalls Out-of-Specification Dental Abutments
Implant Direct Sybron is recalling 60 REPLANT 5.0mmD Abutments because they are out of specification and cannot be properly fitted to implants.
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 2/5 (Moderate).
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 the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional defect (inability to fit the implant) rather than a direct safety risk like infection or injury, fitting the criteria for a moderate severity score.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 60 units of REPLANT 5.0mmD Abutments, Part number 6050-52-60. The affected units are identified by lot numbers 45353, 66011, and 75850.
The recall was initiated because the abutments are out of specification. As a result, clinicians are unable to fit and engage the abutment with the implant. The affected products were distributed in California, Florida, Georgia, Illinois, Louisiana, Michigan, Montana, North Carolina, New Jersey, New York, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, and Washington, as well as in Jordan, Great Britain, Germany, Spain, Italy, and Poland.
Clinicians and patients should stop using the affected abutments and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Hazard
- Affected units
- 60
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 (3)
- Lot numbers: 45353
- 66011
- and 75850
Distribution
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