Zimmer Biomet Recalls Hip Implants Due to Packaging Residue
Zimmer Biomet is recalling specific Versys hip prostheses because LDPE packaging may leave residue on 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 packaging residue on a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific lots of Versus 7.5 IN BEADED FC hip prostheses. The recall involves 13,227 units distributed nationwide in the US and in 24 other countries, including Argentina, Australia, Brazil, and Canada.
The recall is due to a packaging issue where the LDPE bag may adhere to the highly polished surface of the implant. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the affected devices.
The recalled product
- Product
- VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 13,227
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 48 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 48 products in this recall →Related recalls
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Similar recalls
- ModerateZimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion
FDA (Devices) · 2016-03-02
- ModerateZimmer Biomet Recalls Versus Hip Prostheses Due to Packaging Adhesion
FDA (Devices) · 2016-03-02
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