Agency classClass IIOur severity:High FDA (Devices)·Z-1537-2018·Announced 2018-05-09

Zimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors

Zimmer Biomet is recalling 30 modular hip head components because two lots of different sizes were potentially commingled. This error could lead to the use of an incorrect sized head, causing surgery delays or dislocation.

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: The recall involves a high-risk medical device where the use of an incorrect component could result in dislocation, a significant injury, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Zimmer Biomet, Inc. is recalling 30 units of the Modular Head Component, Biomet Hip System (Item No. 163669). This device is a metal/polymer semi-constrained cemented prosthesis used in total hip arthroplasty. The recall involves lot 276760.

The recall was initiated because two lots of different sized modular heads were potentially commingled. The use of an incorrectly sized head component poses risks of delay in surgery and dislocation.

The affected devices were distributed nationwide in the United States in the states of Alabama, Arkansas, Florida, Georgia, Indiana, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Texas, and Virginia. They were also distributed in Canada, Costa Rica, and Chile. Patients and healthcare providers should contact Zimmer Biomet for instructions on how to proceed with the recall.

The recalled product

Product: Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: dislocation
surgery-delay
Affected units: 30

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 276760

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Biomet, Inc. 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 · Zimmer Biomet, Inc.

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Same hazard · dislocation