Smith & Nephew Recalls BIORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling BIORAPTOR 2.9 mm 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 is classified as FDA Class II. The hazard involves a potential breach of the sterile barrier, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling the BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture (Part Number: 72200775). The recall involves 43,385 units distributed worldwide, including the United States, Canada, Europe, Asia-Pacific, and other regions.
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 compromise the sterility of the medical device.
The recalled product
- Product
- BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Hazard
- Affected units
- 43,385
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 50252371
- 50252817
- 50252818
- 50253051
- 50253556
- 50254393
- 50255140
- 50255943
- 50257230
- 50257886
- 50258390
- 50258813
- 50259145
- 50259748
- 50259820
- 50260127
- 50261934
- 50263317
- 50263909
- 50264101
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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