The Recall Desk
ModerateFDA (Devices)·Z-2507-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

Biomet 3i, LLC is recalling Conical Abutment Gold Standard ZR 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. The hazard involves packaging integrity (unsealed pouches) rather than a direct defect in the implant material itself, and no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomet 3i, LLC is recalling Conical Abutment Gold Standard ZR Dental implants. The recall was initiated because pouches containing the devices may not have been sealed during the packing process.

The recall covers 1,648,273 devices. The affected items include codes SCA001, SCA002, SCA003, SCA004, SCA055, SWCA51, SWCA52, SWCA53, SWCA54, and SWCA55. These products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected devices and contact Biomet 3i, LLC for further instructions.

The recalled product

Product
Conical Abutment Gold Standard ZR TM 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 (9)

  • Items: SCA001
  • SCA002
  • SCA003
  • SCA004
  • SCA055
  • SWCA51
  • SWCA52
  • SWCA53
  • SWCA54 and SWCA55.

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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