Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Residue
Zimmer Biomet is recalling Versys 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 explicitly states no illnesses or injuries are reported, and the hazard is a packaging defect (residue) rather than a high-risk pathogen or structural failure.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of the Versys 6 Inch Beaded FC 12x160mm LM Body Ext Neck Versys Beaded Fullcoat Revision Hip Prosthesis. The recall involves specific item and lot numbers distributed worldwide, including the United States and 23 other countries.
The recall is due to a packaging defect 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 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 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 13,227
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item Number: 00-7843-012-56 Lot Numbers: 62089495 11007679 62097295
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.
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