Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 154 sterile bone fixation screws distributed nationwide due to insufficient sealer calibration data.
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. The hazard is a potential sterility assurance issue due to insufficient calibration data, which is a significant risk but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause harm).
Plain-English summary
Zimmer Manufacturing B.V. is recalling 154 units of sterile bone fixation screws, specifically Product 4 under product code HWC. The affected items include various sizes of 2.0 mm and 2.7 mm cortical screws, such as cruciform and hex head designs. These devices are intended for implantation to fix bone fractures or for bone reconstructions.
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 source text confirms that the affected products are sterile. The recall covers 17 specific lot numbers, including 61951256, 62230459, and 61907760.
The affected products were distributed nationwide in the United States. Healthcare providers and facilities that have received these specific lots should stop using the devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CRUCI 47482003403 2.0 X 34 CORT SCREW CRUCI 47482003603 2.0 X 36 CORT SCREW…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 154
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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