Small Bone Innovations Recalls Radial and Ulnar Stem Implants
Small Bone Innovations is recalling 2,036 radial and ulnar stem implants due to a risk of sterile packaging breach.
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 and involves a packaging integrity issue (sterile pouch breach) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Small Bone Innovations, Inc. is recalling 2,036 units of rHead and uHead radial and ulnar stem implants. The affected devices are packaged in a sterile pouch inside a shrink-wrapped box. The recall was initiated because of an increased risk of the implants breaching the sterile pouches.
The recall was expanded on December 20, 2013, to include additional devices such as the rHead lateral assembly, radial head implant, Uni-elbow lateral assembly, and ReMotion components. The affected products were distributed nationwide in the United States, as well as in Canada and Mexico.
Healthcare providers and patients should stop using these devices and contact Small Bone Innovations, Inc. for further instructions. The recall covers all item numbers and lot numbers for the specified products.
The recalled product
- Product
- Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma C
- Manufacturer
- Small Bone Innovations, Inc.
- Affected units
- 2,036
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)
- all item numbers and lot numbers.
Distribution
Distributed nationwide across the United States.
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