Zimmer Biomet Recalls NEXGEN GSF Porous Femoral LPS Flex Implants
Zimmer Biomet is recalling NEXGEN GSF Porous Femoral LPS Flex implants because LDPE packaging may leave residue on the polished 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 polished surface, which is a quality control issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of NEXGEN GSF Porous Femoral LPS Flex Size F, Right implants. The recall is due to a packaging issue where the LDPE bag may adhere to the highly polished surface of the implant, leaving residue or material on the device after it is removed from the bag.
These devices are indicated for patients with painful or disabling knee joints due to osteoarthritis or traumatic arthritis, previous tibial condyle or plateau fractures, varus or valgus deformities, or revision of previous arthroplasty procedures. The devices are designed for cemented use only. The affected units were distributed worldwide, including the United States and numerous international markets.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these specific implants.
The recalled product
- Product
- NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or v
- 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 (2)
- 00-5762-016-52 Knee LPS-FLEX GSF POR FEM
- F-R
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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