The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2420-2016·Announced 2016-08-24

Biomet 3i Recalls Gold-Tite Hexed Retaining Screws Due to Sealing Defects

Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing. The recall covers 1,648,273 units distributed worldwide.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a packaging defect (unsealed pouches) rather than a direct material defect, and no specific injuries or illnesses are reported in the source text, placing it in the Moderate range.

Plain-English summary

Biomet 3i, LLC is recalling Gold-Tite Hexed Retaining Screws (Item: GSH30) used in dental implants. The recall was initiated because pouches containing the screws may not have been sealed during the packing process. This defect could potentially compromise the sterility or integrity of the product.

The recall affects 1,648,273 units. The specific lots subject to the recall are 1071150, 1071151, 1071152, and 1071190. These products were distributed nationwide in the United States, including Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to foreign consignees in numerous countries worldwide.

Healthcare professionals and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor for credit or replacement, in accordance with the recall instructions.

The recalled product

Product
Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 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 (4)

  • Lot # 1071150
  • 1071151
  • 1071152
  • and 1071190

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 →

Similar recalls