Zimmer Astel Femoral Head Recall Due to Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling sterile Astel femoral heads for hip arthroplasty 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves insufficient calibration data for a sterile medical device, which poses a risk of harm, but the source text does not report specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific lots of sterile Astel femoral heads used in total or hemi hip arthroplasty. The recall is initiated 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 identified by specific item numbers and lot numbers, including 805002802, 805002805, 805002803, 805002804, and 805002801. The recall covers products distributed nationwide in the United States.
Healthcare providers and patients should verify if their devices match the listed item and lot numbers. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in…
- Manufacturer
- Zimmer Manufacturing B.V.
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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