Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 hip prosthesis components because the 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 involves a medical device where a potential for adverse tissue reactions exists but has not been explicitly reported as an injury or illness in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 412 units of the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 45mm (Item Number: 00-8065-542-26). This product is a hip prosthesis component distributed nationwide in the United States.
The recall was initiated because the sterilant (hydrogen peroxide) used in the manufacturing process 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 components.
Healthcare providers and patients who have received this specific hip prosthesis component should contact Zimmer Biomet or their healthcare provider for further instructions on how to proceed.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-542-26 Hip prosthesis component
- 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.
See all 75 products in this recall →Related recalls
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