Agency classClass IIOur severity:High FDA (Devices)·Z-0843-2022·Announced 2022-04-06

Hip prosthetic femoral head component size and offset labeling mismatch

Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a surgical implant component with a product mix and labeling mismatch. No illnesses or injuries are reported in the source. The mismatch represents a risk-of-harm to patients if incorrect prosthetic components are implanted, meeting the rubric criterion for high-severity recalls of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling 40 units of Biolox delta Ceramic V40 Femoral Head (Catalog Number 6570-0-232, Lot Number 89546202) due to a potential product mix where the size and/or offset of the component inside the package does not match the label on the package.

This product mix could result in the wrong component being selected and used during surgery, as the physical component received may not correspond to what the package labeling indicates.

The affected components were distributed worldwide, including to the United States (Arizona, California, Colorado, Florida, Georgia, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas) and internationally (Canada, China, Japan, Spain, United Kingdom, Netherlands, Germany, Belgium). Healthcare providers and hospitals that received components from lot number 89546202 should check their inventory against the lot number.

Healthcare facilities should not use these components for surgical procedures. Affected facilities should contact Howmedica Osteonics Corp. for replacement units, refunds, or further instructions.

The recalled product

Product: Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Manufacturer: Howmedica Osteonics Corp.
Category: Medical Device — Orthopedic / Hip Prosthetic
Hazard: product-mix
size-mismatch
labeling-error

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 (1)

Lot Number: 89546202 GTIN: (01)04546540608536(17)261020(10)89546202

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Howmedica Osteonics Corp. 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 2 products in this recall →

Same manufacturer · Howmedica Osteonics Corp.

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Same hazard · product mix