Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide 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 high-risk medical device where a potential for adverse tissue reactions exists, but the source text explicitly states that the risk cannot be ruled out rather than confirming reported injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 412 units of the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene (Item Number: 00-8065-548-26). The product is an acetabular cup hip prosthesis component with an internal diameter of 26 mm and an external diameter of 51 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 products were distributed nationwide in the United States. Healthcare providers and facilities that have received these specific acetabular cups should contact Zimmer Biomet for instructions on how to handle the devices and manage any implanted components.
The recalled product
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-26
- 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
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · adverse tissue reaction
See all →- HighCodman Cranial Access Kits Recall: Incorrect Expiration Dates on Labels
FDA (Devices) · 2022-03-30
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns
FDA (Devices) · 2020-11-11