Smith & Nephew Recalls Footprint Ultra PK Suture Anchors Due to Sterile Breach Risk
Smith & Nephew is recalling 125,196 Footprint Ultra PK Suture Anchors because packaging movement may displace the tip protector, creating a sterile breach.
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 risk-of-harm product (sterile breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling 125,196 units of the Footprint Ultra PK Suture Anchor 4.5 (Part Number 72202901). The recall covers specific lot numbers distributed nationwide and in numerous foreign countries.
The recall was initiated because the space between the device and its packaging permits excessive movement. This movement could potentially lead to the displacement of the anchor's tip protector, which may allow the tip of the anchor to create a sterile breach.
Healthcare providers and facilities that have received these devices should check their inventory for the affected lot numbers. If the devices are found, they should be removed from use and returned to Smith & Nephew, Inc. according to the company's instructions.
The recalled product
- Product
- Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 125,196
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew, Inc. 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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