Smith & Nephew Recalls RAPTORMITE Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling RAPTORMITE 3.7 mm PLLA suture anchors because pinholes in primary pouches may breach the sterile barrier.
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 involves a potential breach of the sterile barrier for a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling RAPTORMITE 3.7 mm PLLA with two ULTRABRAID Sutures Size 0 and Needles, Part Number 72201805. The recall involves 1,965 units distributed in the United States and internationally.
The recall was initiated because pinholes were detected in a small number of primary pouches. These pinholes may constitute a breach of the sterile barrier, which could potentially compromise the sterility of the medical device.
The affected products were distributed nationwide in the United States and in various countries across Europe, Asia-Pacific, and the Americas. Healthcare providers and facilities should check their inventory for the specific part number and lot codes listed in the official recall notice. Users should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 1,965
Distribution
Part of a larger recall action
This product is one of 26 recalled by Smith & Nephew, Inc. Endoscopy Division 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 26 products in this recall →Related recalls
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