Zimmer Recalls CoCr Hip Replacement Heads Due to Packaging Adhesion
Zimmer, Inc. is recalling CoCr heads used in total hip replacements because the packaging bags adhere to the 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, but the source text describes a packaging adhesion issue without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Zimmer, Inc. is recalling CoCr heads used in total hip replacement procedures. The recall is due to a packaging defect where the low density polyethylene (LDPE) bags used to package the implants adhere to the highly polished surface of the devices.
The affected products are identified by Part Number Range 01.01012.405/408. The source text notes that the product was not distributed in the United States, although the distribution pattern lists worldwide distribution including the US and numerous other countries. The total quantity involved is 60,406,406 units.
Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- CoCr Head (Not distributed in the United States) Used in total hip replacement.
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 604,064
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:01.01012.405/408
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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