Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling sterile 1.5 x 6 Cortical 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 temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or fatalities, and the hazard is related to packaging calibration data rather than a confirmed biological or structural failure.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific sterile bone fixation fasteners, specifically 1.5 x 6 Cortical Screws (Item no. 47481500601, Product Code JWH). The recall is limited to Lot No. 61889944.
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 intended to be implanted for the fixation of bone fractures, bone reconstructions, or as guide pins.
The affected products were distributed nationwide in the United States. Healthcare providers and patients should contact Zimmer Manufacturing B.V. for instructions on how to handle the recalled devices.
The recalled product
- Product
- Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE 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 rod…
- Manufacturer
- Zimmer Manufacturing B.V.
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.: 61889944
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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