Biomet 3i Protection Caps Recalled for Inadequate Biocompatibility Testing
Biomet 3i is recalling specific Protection Caps due to inadequate biocompatibility testing. The devices are distributed worldwide, including the US.
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, which typically indicates a moderate risk. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is related to testing adequacy rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Biomet 3i, LLC is recalling 30,111 units of the BIOMET 3i Provide Protection Cap (Catalog # PPC484, PPC485, PPC654, and PPC655). These medical devices are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible.
The recall was initiated because of inadequate biocompatibility testing. The affected devices were distributed worldwide, including nationwide in the United States and in numerous other countries such as Canada, Australia, and Germany.
Consumers and healthcare providers should stop using the affected devices and contact Biomet 3i, LLC for further instructions on the recall.
The recalled product
- Product
- BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accesso
- Manufacturer
- Biomet 3i, LLC
- Hazard
- Affected units
- 30,111
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)
- Model Number: PPC484
- Lot Numbers: 970773
- 977566
- 987984
- 1003033
- 1038519
- 1038520
- 1045556
- 1046268
- 1054540
- 1059416
- 1059512
- 1065495
- 1065497
- 1071762
- 1071763
- 1073161
- 1073163
- 1108328
- 1128077
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Biomet 3i, 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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