Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components
Zimmer Biomet is recalling 412 acetabular cup 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 is classified as FDA Class II and involves a risk of adverse tissue reactions, but the source text explicitly states that the potential for these reactions cannot be ruled out rather than confirming reported injuries or hospitalizations, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 412 units of the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene (I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm, Number: 00-8065-658-32). The recall covers all lots of this specific product, which was distributed nationwide in the United States.
The recall was initiated because the hydrogen peroxide sterilant used in 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.
This recall is classified as Class II by the U.S. Food and Drug Administration. Healthcare providers and patients who have received this specific implant should contact Zimmer Biomet or their healthcare provider for further instructions regarding the device.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-32
- 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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