Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 1,777 sterile interlocking intramedullary screws 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is related to packaging calibration data rather than a direct structural defect or reported injury, fitting the Moderate severity criteria.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 1,777 units of sterile interlocking intramedullary (IM) screws, including large, medium, and small sizes. The recall affects products under product code HSB that were packaged in the firm's Building II between August 2010 and April 2013.
The recall was initiated because of insufficient sealer calibration data for the affected sterile products. The devices are intended to be implanted into the medullary canal of long bones for the fixation of fractures.
The affected products were distributed nationwide in the United States. Consumers and healthcare providers should check their inventory against the specific lot numbers listed in the official recall notice and contact the manufacturer for further instructions.
The recalled product
- Product
- Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555 INTERLOCKING IM SCREW LG 225305055 INTERLOCKING IM SCREW LG 225305555…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 1,777
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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