Biomet 3i Low Profile Abutment Recall for Unsealed Packaging
Biomet 3i is recalling 458 low profile abutment impression copings because a limited number of product pouches may not have been sealed during packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because the hazard is limited to a packaging defect (unsealed pouches) with no reported injuries, illnesses, or functional device failures mentioned in the source text.
Plain-English summary
Biomet 3i, LLC is recalling 458 units of the BIOMET 3i Low Profile Abutment (Non-Hexed) Pick-Up Impression Coping. This endosseous dental implant abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. The affected products are identified by Part # LPCPIC2 and include Lot #s 2015112084, 2016011162, 2016011163, 2016031299, 2016041629, and 2016042021.
The affected units were distributed worldwide to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal, and Sweden. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these specific units.
The recalled product
- Product
- BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 458
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 (5)
- Part # LPCPIC2 Lot #'s 2015112084
- 2016011162
- 2016011163
- 2016031299
- 2016041629 and 2016042021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 36 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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Similar recalls
- LowBiomet 3i Recalls Pick-Up Impression Coping Dental Implants
FDA (Devices) · 2016-08-24
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