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.
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 risk-of-harm product (medical device) where the hazard is a potential adverse tissue reaction, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 412 units of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene components. The specific product number is 00-8065-558-26, with an internal diameter of 26 mm and an outer diameter of 61 mm. The recall covers all lots of this specific product configuration.
The recall was initiated because the hydrogen peroxide sterilant used in the manufacturing process 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.
The affected products were distributed nationwide in the United States. This recall is classified as Class II by the FDA. Patients who have had these specific hip prosthesis components implanted should contact their healthcare provider to discuss the recall and any potential next steps.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-26
- 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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