Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 12 sterile bone fixation screws due to insufficient sealer calibration data. The 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 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 score when no specific injuries or illnesses are reported in the source text. The hazard is related to packaging calibration rather than a direct material defect or contamination.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 12 units of sterile bone fixation screws, specifically item numbers 47493501001 and 47493501801. These devices are metallic fasteners intended for implantation to fix bone fractures or for bone reconstruction. 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 and were distributed nationwide in the United States. The specific lot numbers involved are 61851308 and 61851309. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should check their records for these specific item numbers and lot numbers. If these products have been implanted, patients should contact their healthcare provider for guidance. If the products have not yet been used, they should be returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Product 6 consists of all products under product code HWC, and same usage: Item no: 47493501001 3.5 X 10 CORT SCREW SELFT 47493501801 3.5 X 18 CORT SCREW SELFT Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot no: 61851308 61851309
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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