Implant Direct Sybron Recalls GoDirect Dental Implants Due to Tool Error
Implant Direct Sybron is recalling GoDirect Implants because some consignees received the wrong tool to drive the implant to bone level.
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. The hazard involves a missing or incorrect tool, which is a functional defect rather than a direct contamination or structural failure, fitting the criteria for a moderate severity recall.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling the GoDirect Implants, part of the Spectra-System Dental Implant 2008 system. The recall involves 2,033 units of dental implant fixtures and prosthetic devices.
The recall was initiated because some consignees did not receive the correct tool required to drive the implant to bone level. The affected products were distributed nationwide to numerous states and internationally to Canada, Honduras, and the Dominican Republic.
Consumers and healthcare providers should stop using the affected GoDirect Implants and contact the manufacturer for further instructions.
The recalled product
- Product
- The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 2,033
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 Number: 29707
- 29708
- 29709
- 32444
- 37438
- 38159
- 39506
- 40394
- 40542
- 44661
- 46030
- 50644
- 50824
- 51092
- 51249
- 52798
- 54274
- 54275
- 54617
- 55407
Distribution
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