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 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 and involves a medical device where the manufacturer cannot rule out the potential for adverse tissue reactions, meeting the criteria for a Severe rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling 412 units of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene components. The specific item number is 00-8065-554-22, with an internal diameter of 22 mm and an external diameter of 57 mm. The recall covers all lots of this product, which was distributed nationwide in the United States.
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. As a result, the company cannot rule out the potential for adverse tissue reactions in patients who have received these implants.
This recall is classified as Class II by the U.S. Food and Drug Administration. Patients who have had these specific hip prosthesis components implanted should contact their healthcare provider to discuss the recall and determine if any further medical evaluation or action is necessary.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 57 mm Item Number: 00-8065-554-22
- 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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