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 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 potential for adverse tissue reactions cannot be ruled out, fitting the rubric criterion 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, 59 mm, Number: 00-8065-656-32). 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. The manufacturer notes that the potential for adverse tissue reactions cannot be ruled out.
The affected units were distributed nationwide in the United States. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the affected devices.
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, 59 mm Number: 00-8065-656-32
- 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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