The Recall Desk
ModerateFDA (Devices)·Z-2517-2016·Announced 2016-08-24

Biomet 3i Recalls EP Healing Abutment Dental Implants Due to Sealing Issues

Biomet 3i, LLC is recalling certain EP Healing Abutment dental implants because pouches may not have been sealed during packing.

What this means for you

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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The specific defect is a packaging sealing issue, which is a lower-risk hazard compared to active contamination or structural failure, fitting the Moderate severity criteria for voluntary precautionary or minor labeling/packaging errors.

Plain-English summary

Biomet 3i, LLC is recalling 1,648,273 units of certain EP Healing Abutment dental implants. The recall was initiated because pouches containing the devices may not have been sealed during the packing process.

The affected products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign consignees. The specific item codes subject to this recall include IMHA352, IMHA353, IMHA356, ITHA58, ITHA63, ITHA64, ITHA66, ITHA68, ITHA73, ITHA74, ITHA76, ITHA78, IWTH52, IWTH54, IWTH56, IWTH58, IWTH562, IWTH564, IWTH566, IWTH568, IWTH572, IWTH573, IWTH574, IWTH576, IWTH578, IWTH62, IWTH63, IWTH64, IWTH66, IWTH68, IWTH672, IWTH673, IWTH674, IWTH676, and IWTH678.

Healthcare professionals and consumers should check their inventory for these specific item codes. If the product is found, it should be removed from use and returned to Biomet 3i, LLC according to the company's instructions.

The recalled product

Product
Certain EP Healing 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 (20)

  • Items: IMHA352
  • IMHA353
  • IMHA356
  • ITHA58
  • ITHA63
  • ITHA64
  • ITHA66. ITHA68
  • ITHA73
  • ITHA74
  • ITHA76
  • ITHA78
  • IWTH52
  • IWTH54
  • IWTH56
  • IWTH58
  • IWTH562
  • IWTH564
  • IWTH566
  • IWTH568
  • IWTH572

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 · packaging defect

See all →