Zimmer Biomet Recalls Hip Implants Due to Packaging Residue
Zimmer Biomet is recalling specific Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical implant) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of the Versus 7.5 Inch Beaded FC Rev 13.5x190mm Straight Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. The recall involves Item Number 00-7843-013-18 and Lot Number 62158840. These devices were 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. The FDA has classified this as a Class II recall.
Healthcare providers and patients who have received or are considering these specific hip implants should contact Zimmer Biomet for further instructions. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- 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: 00-7843-013-18 Lot Number: 62158840
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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