Zimmer Precoat Tibia Plates Recalled for Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 39 sterile precoat tibia plates used in 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 hospitalizations, injuries, or illnesses. The hazard is a potential sterility issue due to calibration data, which fits the criteria for a moderate severity score.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 39 units of the STD PRECOAT TIBIA PLATE S (Item no. 598003712), a sterile medical device used 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 were distributed nationwide in the United States. The recall covers specific lot numbers, including 61678240, 61838251, and 61838252, among others. The source text does not report any illnesses or injuries associated with these devices.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to the manufacturer or the designated recall coordinator.
The recalled product
- Product
- Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 39
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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