Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving potential adverse health consequences (such as adverse tissue reactions) are categorized as Severe.
Plain-English summary
Zimmer Biomet, Inc. is recalling 412 units of the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene (Item Number: 00-8065-544-22). The affected product is a hip prosthesis component with an internal diameter of 22 mm and an outer diameter of 47 mm. The recall covers all lots of this specific item number.
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. As a result, the manufacturer cannot rule out the potential for adverse tissue reactions in patients who have received or may receive these components.
The recalled units were distributed nationwide in the United States. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-22
- 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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