Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
Zimmer Biomet is recalling specific 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 medical device where a risk of harm (adverse tissue reactions) exists but has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene (I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm; Number: 00-8065-646-32). The recall covers all lots of this specific product distributed nationwide in the United States.
The recall was initiated because the sterilant (hydrogen peroxide) used in the acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. As a result, the potential for adverse tissue reactions cannot be ruled out.
Healthcare providers and patients who have received this specific implant should contact Zimmer Biomet or their healthcare provider for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
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, 49 mm Number: 00-8065-646-32
- Manufacturer
- Zimmer Biomet, Inc.
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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FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11