Zimmer Biomet Recalls Versus Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 1,305 Versus 6-inch hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging defect (adhesion) rather than a direct structural failure or reported injury, fitting the criteria for a moderate severity recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,305 units of the Versus 6 Inch Beaded FC 1 prosthesis, a semi-constrained total and hemi-hip replacement device. The recall was initiated because the low-density polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface.
The affected devices were distributed worldwide, including nationwide in the United States and to numerous international locations such as Canada, the United Kingdom, Germany, and Japan. The recall covers specific item numbers and lot numbers identified in the agency's documentation.
Consumers and healthcare providers should stop using the affected devices and contact Zimmer Biomet for further instructions on how to proceed with the recall.
The recalled product
- Product
- VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,305
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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 21 products in this recall →Related recalls
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