Smith & Nephew FOOTPRINT Ultra PK Suture Anchor Recall for Sterile Breach Risk
Smith & Nephew is recalling FOOTPRINT Ultra PK Suture Anchors because excessive movement in packaging could displace the tip protector, potentially causing a sterile breach.
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 risk-of-harm product (sterile breach) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling 125,196 units of the FOOTPRINT Ultra PK Suture Anchor, 5.5mm (Part Number: 72202902). 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. If the tip protector is displaced, the tip of the anchor could create a sterile breach.
The source text does not specify specific consumer actions or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
- 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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