Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling specific lots of sterile 4.5 x 26 Cortical Screws due to insufficient sealer calibration data during packaging.
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 involves insufficient sealer calibration data, which is a quality control issue that may compromise sterility, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Manufacturing B.V. is recalling two units of sterile 4.5 x 26 Cortical Screws (Item No. 47484502601) under product code HWC. These devices are metallic bone fixation fasteners intended for implantation to fix bone fractures or for bone reconstructions. The affected lots are 61854116 and 61930079.
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 distribution pattern is listed as US Nationwide Distribution.
Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected devices. No specific instructions for return or disposal are provided in the source text.
The recalled product
- Product
- Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 2
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:61854116 61930079
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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