Smith & Nephew MOSAICPLASTY Harvesting System Recalled for Packaging Breach
Smith & Nephew is recalling MOSAICPLASTY DP- Disposable Harvesting Systems 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, and the hazard involves a compromised sterile medical device used in surgery, which presents a significant risk of harm (infection) even though specific injury reports are not detailed in the source text.
Plain-English summary
Smith & Nephew, Inc., Endoscopy Div. is recalling the MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile (Part Number: 7209235). The recall involves 1,287 units of the device, which is intended for arthroscopic (knee and ankle) and open osteochondral grafting fixation for osteochondral (cartilage) defects.
The recall was initiated because the sterility of the device is compromised due to a breach in the packaging. This defect poses a risk of infection or other adverse health consequences if the non-sterile device is used in a surgical procedure.
The affected units were distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and South America. Healthcare providers and patients who have used or possess this specific device should stop using it and contact Smith & Nephew for instructions on return or replacement.
The recalled product
- Product
- Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Div.
- Affected units
- 1,287
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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