Zimmer Manufacturing Recalls Sterile Knee Patella Components Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 512 sterile I/B II Knee Domed Patella components for total knee arthroplasty due to insufficient sealer calibration data.
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 illnesses, injuries, or hospitalizations. The hazard is a potential sterility issue due to calibration data, which fits the criteria for a moderate risk where harm is possible but not reported.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 512 units of sterile I/B II Knee Domed Patella components (Item nos. 522001700, 522001800, and 522001900) intended for use in total knee 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 and were distributed nationwide in the United States. The specific lot numbers involved in this recall are 61932449, 62126613, 62204611, 62213348, 62406239, 62203954, 62204587, 62332733, 62236654, and 62406245.
Healthcare providers and facilities should identify and quarantine these specific sterile components. Users should contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 512
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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