Zimmer Multipolar Bipolar Cup Metal Shell Recall Due to Packaging Adhesion
Zimmer, Inc. is recalling Multipolar Bipolar Cup Metal Shell implants because the packaging bag adheres to the device 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 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, but the source text describes a packaging adhesion issue without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling Multipolar Bipolar Cup Metal Shell implants, indicated for the treatment of fracture dislocation of the hip. The affected products are identified by part numbers in the range 00-5001-038/072-00. The recall involves 72,806 units.
The recall was initiated because the low density polyethylene (LDPE) bag used to package the implants adheres to the highly polished surface of the devices. This packaging defect may affect the integrity of the sterile barrier or the condition of the implant surface.
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 Mexico. Healthcare providers and facilities that have received these specific part numbers should stop using the affected implants and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 72,806
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)
- Part Number Range: 00-5001-038/072-00
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.
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