Zimmer Biomet Recalls Hip Implants Due to Packaging Residue
Zimmer Biomet is recalling specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.
What this means for you
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 does not report any illnesses or injuries, and the hazard is limited to packaging residue on the implant surface, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of the Versus 6 Inch Beaded FC 14x160mm Std Body Ext & Std Neck Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. The recall affects specific item numbers and lot numbers distributed worldwide, including the United States and 24 other countries.
The recall was initiated because the LDPE bag packaging for these highly polished implants may adhere to the surface. This adhesion can leave residue or material from the LDPE bag on the implant after it is removed from the packaging.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to handle the affected devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK 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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