Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups 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 involves a high-risk medical device where a potential for adverse tissue reactions exists due to unverified sterilant biocompatibility, but no specific injuries or illnesses are reported in the source text, fitting the 'High' 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. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm (Number: 00-8065-654-22). The recall covers all lots of this specific product configuration.
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.
The affected units were distributed nationwide in the United States. 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 action is necessary.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-22
- 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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