Zimmer Manufacturing Recalls Sterile Bone Fixation Appliances Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 1,209 units of sterile metallic bone fixation appliances 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 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, which typically corresponds to a moderate severity level where the hazard is unlikely to cause serious adverse health consequences but may cause temporary or medically reversible harm. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 1,209 units of sterile metallic bone fixation appliances and accessories. The recall affects products under product code JDI, including various sizes and revisions of CPT 12/14 COCR components. These devices are intended for the fixation of fractures in long bones, joint fusion, or surgical procedures involving bone cutting.
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. The recall covers US Nationwide Distribution.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of these devices. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 1,209
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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