Zimmer Manufacturing Recalls Sterile Femoral and Humeral Intramedullary Nails
Zimmer Manufacturing B.V. is recalling 1,622 sterile femoral and humeral intramedullary nails 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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 1,622 units of sterile femoral and humeral intramedullary nails. The recall covers various diameters of M/DN FEM IM Nails and M/DN HUMERAL I/M Nails distributed nationwide in the United States.
The recall was 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 sterile.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA…
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 1,622
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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