Implant Direct Recalls RePlant Angled Abutments Due to Design Defect
Implant Direct Sybron Manufacturing is recalling 205 RePlant Angled Abutments because they are oversized due to a design specification issue.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a design defect without reported harm.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 205 units of the RePlant Angled Abutment, Part Number 6050-52-60. The recall is being conducted because the product has an issue with its design specification, resulting in an oversized condition.
The affected units are identified by Lot numbers 50174, 39799, and 49364. These products were distributed in the United States to the following states: CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, and OK. The products were also distributed to foreign locations including CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, and BG.
Consumers and healthcare providers should stop using the recalled abutments and contact the manufacturer for instructions on how to return or replace the product.
The recalled product
- Product
- RePlant¿ Angled Abutment Part Number 6050-52-60
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 205
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 #50174
- 39799
- 49364
Distribution
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