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 sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when there is a potential for adverse health consequences such as tissue reactions.
Plain-English summary
Zimmer Biomet, Inc. is recalling 412 units of the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm (Number: 00-8065-554-26). The recall covers all lots of this specific product, which was 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 company cannot rule out the potential for adverse tissue reactions in patients.
This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-26
- 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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FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns
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