Zimmer Modular Hip Cups Recalled for Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling sterile modular hip cups 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential sterility issue due to calibration data gaps, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 30 units of sterile modular cups used in total hip arthroplasty. The affected products include various item numbers for 10-degree, 20-degree, and neutral liners under product code LPH. The recall is due to insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013.
The affected products were distributed nationwide in the United States. The source text does not specify the number of reported illnesses or injuries associated with this recall. Consumers and healthcare providers should check their inventory against the specific lot numbers listed in the official recall notice to determine if they possess affected units.
The recalled product
- Product
- Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 30
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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