Agency classClass IIOur severity:High FDA (Devices)·Z-0396-2021·Announced 2020-11-11

Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

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 risk-of-harm product (medical device) where injury has not yet been reported, and the agency classification is Class II without specific reports of hospitalization or death.

Plain-English summary

Zimmer Biomet, Inc. is recalling 412 units of the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm (Number: 00-8065-956-32). The recall affects all lots of this specific product, which was distributed nationwide in the United States.

The recall was initiated because the sterilant (hydrogen peroxide) used in the acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. As a result, the company cannot rule out the potential for adverse tissue reactions in patients who have received these implants.

This recall is classified as Class II by the U.S. Food and Drug Administration. Patients who have had this specific hip prosthesis component implanted should contact their healthcare provider to discuss the recall and determine if any further evaluation or action is necessary.

The recalled product

Product: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm Number: 00-8065-956-32
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: adverse-tissue-reaction
biocompatibility
Affected units: 412

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)

All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 75 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 75 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

See all →

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FDA (Devices) · 2020-12-30
Moderate
Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
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 · adverse tissue reaction