Zimmer Natural-Knee Flex Femoral Component Packaging Adhesion Recall
Zimmer, Inc. is recalling Natural-Knee Flex Femoral Components because the low-density polyethylene packaging bags adhere to the polished device surfaces.
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 is a packaging adhesion issue without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling the Natural-Knee Flex Femoral Component, a medical device designed to provide increased flexion capability. The recall involves part numbers 00-5410, 5412, 5414, and 5416-013/018-01/02.
The recall was initiated because the low-density polyethylene (LDPE) bags used to package the implants adhere to the highly polished surface of the devices. This packaging defect may affect the handling or integrity of the implant packaging.
The affected devices were distributed worldwide, including the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and others. Healthcare providers and facilities that have received these specific part numbers should contact Zimmer, Inc. for instructions on how to proceed.
The recalled product
- Product
- Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 33,987
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 (4)
- Part Number Range: 00-5410
- 5412
- 5414
- and 5416-013/018-01/02.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Zimmer, 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 13 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide recalled for plastic breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
Same hazard · packaging defect
See all →- HighMD Wipe Outz Numbing Tattoo Wipes Recalled for Child Poisoning Risk
CPSC · 2026-08-27
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12