Zimmer Manufacturing Recalls 6 Degree COCR Femoral Heads for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 209 units of 6 Degree COCR Femoral Heads due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.
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 a potential loss of sterility in a medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 209 units of 6 Degree COCR Femoral Heads (product code JDI) used in total or hemi 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 recall covers specific item numbers including 902602935, 902602835, 902603235, 902603335, 902603600, 902603610, and 902603614, in sizes 28, 32, and 36. The products were distributed nationwide in the United States.
The FDA has classified this as a Class II recall. No illnesses or injuries have been reported in the source text. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36…
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 209
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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