The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2425-2016·Announced 2016-08-24

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

Biomet 3i is recalling specific 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, but the source text describes a packaging defect (unsealed pouches) without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where harm has not been reported.

Plain-English summary

Biomet 3i, LLC is recalling O-Ring Abutments (4.1mm(D) x 4mm(H), Item: OSO40) used in dental implants. The recall involves 1,648,273 units distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

The reason for the recall is that pouches containing the abutments may not have been sealed during the packing process. This packaging defect could potentially compromise the sterility or integrity of the medical device.

Healthcare professionals and patients should stop using the affected O-Ring Abutments. The recall covers specific lot numbers: 1014104, 1022991, 1033058, 1041417, 1052716, 1054542, 1060675, 1069646, 1088483, 1094776, 1106610, 1129686, 1141289, 1168523, 1168829, 1172024, and 996069. Users should contact Biomet 3i for further instructions on returning or replacing the product.

The recalled product

Product
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 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 (17)

  • Lot # 1014104
  • 1022991
  • 1033058
  • 1041417
  • 1052716
  • 1054542
  • 1060675
  • 1069646
  • 1088483
  • 1094776
  • 1106610
  • 1129686
  • 1141289
  • 1168523
  • 1168829
  • 1172024
  • and 996069.

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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