Acufex Access Advanced Positioning Kit Recalled for Missing Sterilization
Smith & Nephew is recalling the Acufex Access Advanced Positioning Kit because the products were shipped to a distribution center instead of the sterilizer and were not sterilized before distribution.
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: This is an FDA Class II recall of unsterilized surgical instruments. While the hazard presents a clear risk of infection, no illnesses or injuries are reported in the source documentation. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scored as High (3).
Plain-English summary
Smith & Nephew, Inc. is recalling the Acufex Access Advanced Positioning Kit (Product Number 72205104). The recall was initiated because products were shipped to the Global Distribution Center instead of being sent for sterilization, and therefore did not undergo the required sterilization process.
The Acufex Access Advanced Positioning Kit is a surgical instrument indicated for use to position and distract the extremity during open and arthroscopic surgical procedures. Unsterilized instruments used in surgical procedures present a risk of infection to patients.
The recall affects 271 units. The affected lot numbers are 50971615, 50971617, and 50967788. Distribution was worldwide, with U.S. distribution in the states of Colorado, Connecticut, Florida, Massachusetts, Maryland, Oregon, Pennsylvania, and Wisconsin, as well as Canada.
The recalled product
- Product
- Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- sterilization-failure
- infection-risk
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 (2)
- Lot Numbers: 50971615
- 50971617 & 50967788
Distribution
Distributed nationwide across the United States.
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