The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2426-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implant O-Ring Abutments Due to Sealing Defect

Biomet 3i is recalling specific lots of O-Ring Abutments for dental implants because pouches may not have been sealed during packing.

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 2/5 (Moderate).

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. The hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or quality control issue without reported injuries, fitting the Moderate severity criteria.

Plain-English summary

Biomet 3i, LLC is recalling O-Ring Abutments (4.1mm(D) x 6mm(H), Item: OSO60) used for dental implants. The recall involves 1,648,273 units from lot numbers 1068337, 1116902, and 997344. The products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

The recall was initiated because pouches containing the abutments may not have been sealed during the packing process. This defect could potentially compromise the sterility or integrity of the medical device.

Healthcare providers and consumers who have these specific lot numbers should stop using the product and contact Biomet 3i, LLC for further instructions on replacement or return.

The recalled product

Product
O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implants
Hazard
Affected units
1,648,273

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 (3)

  • Lot # 1068337
  • 1116902
  • and 997344

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 119 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.

See all 119 products in this recall →

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