Zimmer Manufacturing Recalls Compression Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 3,415 sterile compression screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
What this means for you
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 reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to packaging calibration data rather than a direct material defect or contamination.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 3,415 units of sterile compression screws (product code KTT) distributed nationwide in the United States. The recall involves specific item numbers ranging from 1/2 inch to 1-3/4 inch sizes, including items 47116201900, 47116202300, 47116202200, 47116202400, 47116202100, and 47116202000.
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. These devices are single or multiple component metallic bone fixation appliances intended to be implanted for the fixation of fractures or fusion of joints. The affected products are sterile.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers listed in the recall notice. If the affected products have been implanted, healthcare providers should contact Zimmer Manufacturing B.V. for further instructions regarding patient management and device retrieval.
The recalled product
- Product
- Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47116202400 COMPRESSION SCREW 1-3/4IN 47116202100 COMPRESSION SCREW 1IN 471
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 3,415
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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