Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach
Smith & Nephew is recalling 1,246 units of the MOSAICPLASTY DP Disposable Harvesting System because a packaging breach compromised the device's sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a compromised sterile medical device, which presents a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Smith & Nephew, Inc., Endoscopy Div. is recalling 1,246 units of the MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile (Part Number: 7209237). The recall is due to a breach in the packaging that compromises the sterility of the device. The product is intended for arthroscopic (knee and ankle) and open osteochondral grafting fixation for osteochondral (cartilage) defects.
The affected units were distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and South America. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected devices and contact Smith & Nephew for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Div.
- Affected units
- 1,246
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Smith & Nephew, Inc., Endoscopy Div. 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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