Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures
Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.
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 2/5 (Moderate).
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 defect that could compromise sterility. No illnesses or injuries are reported, and the risk is theoretical based on test failures, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads. These sterile-packaged implants and instruments were distributed worldwide in six different package configurations. The recall is due to packaging design verification test failures.
Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing. During these tests, the devices either breached inner or outer package trays or lost seal integrity. This failure could potentially compromise the sterility of the implants.
The affected products include various sizes of Endo Femoral Heads and Unipolar Components, with expiration dates prior to 2024-01. Consumers and healthcare providers should check their inventory for the specific item numbers listed in the recall notice and contact Zimmer, Inc. for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 972,125
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 (20)
- Item Numbers 00781804100
- 00781804200
- 00781804300
- 00781804400
- 00781804500
- 00781804600
- 00781804700
- 00781804800
- 00781804900
- 00781805000
- 00781805100
- 00781805200
- 00781805300
- 00781805400
- 00781805500
- 00781805700
- 00781806000
- 00781806300
- 00902604101
- 00902604201
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 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 7 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System 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 Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighZimmer Manufacturing Recalls Unipolar Endo Femoral Heads Due to Sealer Calibration Issues
FDA (Devices) · 2016-03-23
- HighZimmer Manufacturing Recalls Unipolar Femoral Heads Due to Sterility Concerns
FDA (Devices) · 2016-03-23
- ModerateZimmer Recalls 12/14 Femoral Heads Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Recalls 6 Degree Femoral Heads Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26
- ModerateZimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
FDA (Devices) · 2017-06-21
- ModerateZimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures
FDA (Devices) · 2017-06-21