Implant Direct Sybron Recalls Guided Surgery Handle Kits Due to Dimensional Defect
Implant Direct Sybron is recalling 84 Guided Surgery Handle Kits because the 2.3mm drill guide inserts have a smaller inside diameter than specifications require.
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, and the source text does not report any illnesses or injuries. The hazard is a dimensional defect in a surgical instrument, which fits the criteria for a moderate severity recall involving a potential risk of harm without reported adverse events.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 84 units of the Spectra-System/Legacy Guided Surgery Handle Kit (Device Listing Number D245883). The recall is due to a manufacturing defect where the inside diameter of the 2.3mm small drill guide inserts is smaller than the specifications require.
The Guided Surgery Handle Kit allows clinicians to drill through a surgical guide to create an osteotomy for dental implant placement. The affected units are identified by Lot 65249 and Sequence Number HE G-HKRev01. The products were distributed nationwide in the United States and internationally to Canada, the Netherlands, Spain, Great Britain, Germany, and Switzerland.
Consumers and healthcare providers should stop using the affected handle kits and contact the manufacturer for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning sof
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Affected units
- 84
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 65249
- Sequence Number HE G-HKRev01
- Device Listing Number D245883.
Distribution
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