SwishPlus Implant Extender Packaging Error Recall
Implant Direct Sybron Manufacturing is recalling SwishPlus Implants because the packaged extender may be upside down in the retainer.
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: This is a Class II recall involving a packaging error (incorrect position of the extender) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 1,117 units of SwishPlus Implants. These devices are intended for use in support for fixed bridgework. The recall covers specific part and lot numbers, including 924108, 924112, 924116, 924806, 924810W, 924812W, and 924814.
The recall is due to a packaging error where the extender packaged with the implant may have been positioned upside down in the plastic retainer. The affected products were distributed worldwide, including in the US, Europe, Canada, Australia, and Japan.
Healthcare providers and patients should check their inventory or records for the specific part and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or their authorized representative.
The recalled product
- Product
- SwishPlus Implant Intended for use in support for fixed bridgework.
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 1,117
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 (9)
- Part No. (Lot No.): 924108 (97347)
- 924112 (64927
- 93563
- 98662)
- 924116 (70543)
- 924806 (99749)
- 924810W (93934)
- 924812W (94204)
- and 924814 (103199).
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Implant Direct Sybron Manufacturing, LLC 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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