The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2506-2016·Announced 2016-08-24

Biomet 3i Recalls Conical Abutment Dental Implants Due to Sealing Defects

Biomet 3i is recalling Conical Abutment Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

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 3/5 (High).

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 a potential sterility breach in a medical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Biomet 3i, LLC is recalling Conical Abutment Dental implants. The recall involves 1,648,273 devices, including items MCA31, MCA33, MCA34, CA001, CA002, CA004, WCA51, and WCA53. The agency classifies this as a Class II recall.

The reason for the recall is that pouches containing the devices may not have been sealed during packing. This defect could affect the sterility of the implants. The products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

Healthcare providers and patients should stop using these specific dental implants. Consumers should contact their healthcare provider or Biomet 3i for instructions on how to proceed with the recall.

The recalled product

Product
Conical Abutment 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 (7)

  • Items: MCA31
  • MCA33
  • MCA34
  • CA001
  • CA002
  • CA004
  • WCA51 and WCA53.

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 →

Related recalls

Same manufacturer · Biomet 3i, LLC

See all →

Same hazard · sterility breach

See all →

Similar recalls