Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 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 the hazard involves a risk of harm (adverse tissue reactions) where injury has not yet been reported, aligning with the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 412 units of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene components. The recall involves the I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm, catalog number 00-8065-952-32. The affected units were distributed nationwide in the United States.
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. The manufacturer states that the potential for adverse tissue reactions cannot be ruled out. The source text does not report any specific illnesses or injuries associated with the use of these devices.
Consumers and healthcare providers who have these specific components should contact Zimmer Biomet for further instructions. The recall covers all lots of the specified product number.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm Number: 00-8065-952-32
- 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.
See all 75 products in this recall →Related recalls
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Same hazard · biocompatibility
See all →- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
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- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Acetabular Hip Prosthesis Components Due to Sterilant Concerns
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