Recall Z-0591-2016— Biomet 3i, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet 3i, LLC, initiated 2015-09-21, terminated 2016-10-12. It names one FDA 510(k) clearance: K934126. 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 accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.. Reason: Inadequate biocompatibility testing..
- Recalling firm
- Biomet 3i, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-21
- Terminated
- 2016-10-12
- Firm location
- Palm Beach Gardens, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
Reason for recall
Inadequate biocompatibility testing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.