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, and the hazard involves potential packaging residue on the implant surface 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 the Versus 6 Inch Beaded FC 13x160mm LM Body Ext Neck & Std Neck Prosthesis. The recall involves 13,227 units distributed worldwide, including the United States and 23 other countries.
The recall was initiated because the LDPE bag packaging for these highly polished hip and knee implants may adhere to the implant 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 proceed with the affected devices.
The recalled product
- Product
- VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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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