Biomet 3i Recall Dental Impression Coping Kits for Biocompatibility Testing
Biomet 3i is recalling 30,111 Provide Impression Coping Kits worldwide due to inadequate biocompatibility testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inadequate biocompatibility testing, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Biomet 3i, LLC is recalling 30,111 units of Provide Impression Coping Kits, including catalog numbers PRK484, PRK485, PRK654, and PRK655. These medical devices are intended for use as accessories to endosseous dental implants in the maxilla and mandible.
The recall was initiated because of inadequate biocompatibility testing. The affected products were distributed worldwide, including in the United States, Canada, and numerous other countries.
The source text does not specify specific instructions for consumers or healthcare providers regarding the return or disposal of these devices.
The recalled product
- Product
- BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 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 a
- 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: PRK484
- Lot Numbers: 929282
- 948311
- 949496
- 949497
- 949668
- 950083
- 952452
- 954303
- 957220
- 957368
- 960733
- 963052
- 963054
- 971802
- 975153
- 977973
- 979767
- 984897
- 987880
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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