The Recall Desk
ModerateFDA (Devices)·Z-2303-2020·Announced 2020-06-17

Biomet 6.5 Cannulated Screw Tap Recalled for Incomplete Design History

Biomet is recalling 6.5 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is procedural (incomplete documentation) rather than a direct physical defect causing harm, fitting the 'Moderate' criteria for low-risk or theoretical hazards without reported adverse events.

Plain-English summary

Biomet is recalling the 6.5 Cannulated Screw Tap (Item Number 110008466), a bone fixation screw intended for temporary internal fixation and stabilization of osteotomies and fractures. The recall involves 6 OUS of the product, specifically Lot Numbers 624820 and 867200.

The recall was initiated because the product was distributed to the field without having completed design history files or design transfer activities. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The product was distributed worldwide, including in the United States (specifically NY, GA, FL, MO) and in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. Healthcare providers and facilities should stop using the affected lots and contact Biomet for further instructions.

The recalled product

Product
Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Manufacturer
Biomet
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
6

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 22 recalled by Biomet 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 22 products in this recall →

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