Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 4,844 Versys 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, but the source text describes a packaging defect (bag adhesion) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 4,844 units of Versys 6 Inch Beaded FC and Versys 8 Inch Beaded FC semi-constrained hip prostheses. The recall involves specific item numbers and lot numbers distributed nationwide in the United States and internationally to numerous countries.
The recall was initiated because the LDPE bag containing the implant adheres to the highly polished implant surface. This packaging defect is the stated reason for the recall action.
Consumers and healthcare providers who have these specific prostheses should contact Zimmer Biomet for further instructions. The affected products are identified by the specific item and lot numbers listed in the official recall documentation.
The recalled product
- Product
- VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 4,844
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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Similar recalls
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