Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Issue
Zimmer Biomet is recalling CR Flex and LPS Flex knee prostheses because the LDPE packaging bag adheres to the polished implant surface.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a packaging-only problem (bag adhesion) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only problems.
Plain-English summary
Zimmer Biomet, Inc. is recalling 18,482 units of CR Flex GSF Porous Femoral, LPS Flex GSF Porous Femoral, and LPS Flex Porous Femoral prostheses. These are semi-constrained, uncemented, porous-coated knee implants indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, or traumatic arthritis.
The recall was initiated because the low-density polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface. This packaging defect is the specific reason for the recall action.
The affected devices were distributed worldwide, including nationwide in the United States and internationally to numerous countries in the Americas, Europe, Asia, and Oceania. Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the recalled devices.
The recalled product
- Product
- CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 18,482
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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 21 products in this recall →Related recalls
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Similar recalls
- ModerateZimmer Biomet Recalls LPS-FLEX Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
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