Zimmer Biomet Recalls Versus 6 Inch Beaded FC 1 Hip Prosthesis
Zimmer Biomet is recalling 130 units of Versus 6 Inch Beaded FC 1 hip prostheses because the packaging bag adheres to the 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, but the hazard is a packaging defect (bag adhesion) rather than a direct biological or structural failure of the implant itself, fitting the criteria for moderate severity.
Plain-English summary
Zimmer Biomet, Inc. is recalling 130 units of the Versus 6 Inch Beaded FC 1 prosthesis, a semi-constrained total and hemi-hip replacement device. The recall is due to a packaging defect where 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 Argentina, Australia, Canada, and the United Kingdom. The recall covers specific item numbers (00-7843-011-16 through 00-7843-016-16) and lot numbers (61760685 through 62120672).
Healthcare providers and patients should check their inventory or medical records for these specific item and lot numbers. If the packaging bag is found to be adhering to the implant, the device should not be used. Zimmer Biomet is the recalling firm responsible for managing this Class II 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
- 130
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.
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