Agency classClass IIOur severity:High FDA (Devices)·Z-1860-2017·Announced 2017-04-26

Zimmer Biomet Recalls Polyethylene Hip Implants Due to Endotoxin Levels

Zimmer Biomet is recalling 28,253 polyethylene hip implant components worldwide because endotoxin levels exceeded process maximum limits.

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 is classified as FDA Class II. The hazard involves endotoxin contamination in medical implants, which poses a risk of harm, but the source text does not report specific illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Zimmer Biomet, Inc. is recalling 28,253 units of various polyethylene implants used in hip arthroplasty. The affected products include Active Articulation ArComXL Bearings, Active Articulation E1 Bearings, Arcos Taper Cap, BIOLOX delta Option Head, E1 RingLoc Bi-Polar, Freedom Constrained Liner +5mm, Hi-Wall ArcomXL All Poly, Rimloc E1 10 Degree Liner, RingLoc +3mm Hi-Wall E1 Liner, and other specific liners and bearings.

The recall was initiated because endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. The agency classification for this recall is Class II.

The affected products were distributed worldwide, including in the United States, Argentina, Australia, Canada, Chile, China, Costa Rica, Ecuador, India, Italy, Japan, South Korea, Malaysia, Mexico, Panama, Singapore, Switzerland, Thailand, and the United Kingdom. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.

The recalled product

Product: various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: endotoxin-contamination
Affected units: 28,253

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

See all →

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FDA (Devices) · 2020-12-30
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High
Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11

Same hazard · endotoxin contamination