Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System Recalled for Packaging Breach
Smith & Nephew is recalling 1,347 units of the MOSAICPLASTY DP- Disposable Harvesting System because a packaging breach 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 involves a sterile medical device where sterility is compromised due to a packaging breach. This creates a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc., Endoscopy Div. is recalling 1,347 units of the MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile (Part Number: 7209236). The recall was initiated because the sterility of the device is compromised due to a breach in the packaging.
The affected product is intended for arthroscopic (knee and ankle) and open osteochondral grafting fixation for osteochondral (cartilage) defects. The recall covers units distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and South America.
Healthcare providers and patients should stop using the affected devices immediately. Smith & Nephew is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Div.
- Affected units
- 1,347
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.
See all 4 products in this recall →Related recalls
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