Zimmer HGP II Acetabular Cup Recall Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 2,236 HGP II Acetabular Cup components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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 source text does not report any illnesses, injuries, or hospitalizations, indicating a theoretical risk rather than a confirmed harm.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 2,236 units of HGP II Acetabular Cup components (Product 33) used in total hip arthroplasty. The recall is being conducted because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile.
The affected items are identified by product code JDI and specific item numbers ranging from 662406515 to 662406560. The recall covers specific lot numbers, including 61674472, 61906696, and 62016799, among others. The products were distributed nationwide in the United States.
Healthcare providers and consumers should stop using these specific components and contact Zimmer Manufacturing B.V. for further instructions or replacement.
The recalled product
- Product
- Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 2,236
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. 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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