Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach
Smith & Nephew is recalling 603 units of the MOSAICPLASTY DP Disposable Harvesting System because a breach in the packaging compromised the device's sterility.
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 3/5 (High).
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. The hazard involves a compromised sterile barrier, which poses a risk of infection (risk-of-harm product), but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Smith & Nephew, Inc., Endoscopy Div. is recalling 603 units of the MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile (Part Number: 7209234). 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 covers specific lot numbers, including 50045108, 50216535, and 50337080, among others.
Healthcare providers and patients should stop using the affected devices and contact Smith & Nephew for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Div.
- Affected units
- 603
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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