Zimmer Biomet Recalls Versus Hip Stems Due to Packaging Residue
Zimmer Biomet is recalling 13,227 Versus hip stems 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 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 13,227 units of the Versus 6 Inch Beaded FC Stem, a semi-constrained hip prosthesis. The affected items are distributed worldwide, including the United States and 23 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 bag on the implant after it is removed from the packaging.
The source text does not specify instructions for consumers or healthcare providers regarding the handling of these devices.
The recalled product
- Product
- VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM 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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