Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Residue
Zimmer Biomet is recalling 13,227 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. The hazard involves packaging residue on a medical device, which is a quality defect without reported serious injuries or deaths, fitting the Moderate severity criteria for minor defects or low-risk contamination.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of the Versys 10 Inch Beaded FC Rev 15.0x250mm BWD LT & RT Versys Beaded Fullcoat Revision Hip Prosthesis. The recall involves specific item numbers and lot numbers distributed worldwide, including the United States and numerous international markets.
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.
This recall is classified as Class II by the FDA. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the affected devices.
The recalled product
- Product
- VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
- 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.
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