Zimmer Manufacturing Recalls Anti-Rotation Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling seven ITST Anti-Rotation Screws because of insufficient sealer calibration data. The affected sterile 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is related to packaging calibration rather than a direct structural defect or contamination.
Plain-English summary
Zimmer Manufacturing B.V. is recalling seven units of ITST Anti-Rotation Screws (item numbers 225706565, 225707065, 225708065, 225708565, and 225709065) under product code HSB. The recall is due to 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 recalled devices are intramedullary fixation rods intended to be implanted into the medullary canal of long bones for the fixation of fractures. The affected lots are 62208147, 62208146, 62208148, 62042715, and 62042716. The products were distributed nationwide in the United States.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further information regarding the recall and potential replacement or repair options.
The recalled product
- Product
- Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-ROTATION SCREW 225708065 ITST ANTI-ROTATION SCREW 225708565 ITST ANTI-ROTATION SCREW 225709065 ITST ANTI-ROTATION SCREW Product…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 7
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.: 62208147 62208146 62208148 62042715 62042716
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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