The Recall Desk
ModerateFDA (Devices)·Z-2418-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

Biomet 3i is recalling specific dental implant copings because pouches may not have been sealed during packing, potentially compromising sterility.

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 hazard is a potential sterility issue due to unsealed packaging, which is a moderate risk without reported injuries.

Plain-English summary

Biomet 3i, LLC is recalling certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) dental implants (Item: IWIP50). 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 recall was initiated because the pouches containing the implants may not have been sealed during the packing process. This defect could potentially affect the sterility of the devices.

Affected lots include 1157768-CN, 1160929-CN, 1160930-CN, 1160931-CN, 987129-5, 996343-5, and 998147-5. Healthcare providers and consumers should check their inventory for these specific lot numbers and contact Biomet 3i for instructions on how to proceed.

The recalled product

Product
Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 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)

  • Lot # 1157768-CN
  • 1160929-CN
  • 1160930-CN
  • 1160931-CN
  • 987129-5
  • 996343-5
  • and 998147-5

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

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Same hazard · sterility compromise

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