Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
What this means for you
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, and the source text explicitly states that the manufacturer cannot rule out the potential for adverse tissue reactions, indicating a risk of harm where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 412 units of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene components (Item Number: 00-8065-550-22). The affected product is an acetabular cup with an internal diameter of 22 mm and an external diameter of 53 mm, distributed nationwide in the United States. The recall covers all lots of this specific item.
The recall was initiated because the hydrogen peroxide sterilant used on the acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. As a result, the manufacturer cannot rule out the potential for adverse tissue reactions in patients who have received these components.
This recall affects healthcare facilities and patients who have received the specific Zimmer Biomet acetabular cup components. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or removal of the affected devices.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-22
- Manufacturer
- Zimmer Biomet, Inc.
- 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.
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