Smith & Nephew EVOS Self-Tapping Locking Screws recalled due to switched package labels
Smith & Nephew is recalling 224 units of EVOS Self-Tapping Locking Screws because package labels were switched, creating a risk that incorrect screw sizes could be implanted during surgery.
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: This is a Class II recall involving surgical implant labeling error. Switched package labels create a risk that incorrect size screws could be selected during surgery, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Smith & Nephew is recalling 224 units of EVOS Self-Tapping Locking Screws due to a labeling error. Two products are affected: 3.5MM x 75MM screws (REF 72413575, batch #21FM24289) and 3.5MM x 70MM screws (REF 72413570, batch #21GM04743).
The labels on the packages of these screws were switched, creating a risk that the wrong size screw could be selected and used during surgical procedures.
The affected screws were distributed to healthcare facilities across 25 U.S. states including Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, and Washington. International distribution included Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.
Patients and healthcare providers who may have these screws should verify the package contents and contact Smith & Nephew with any questions or concerns.
The recalled product
- Product
- Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 224
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)
- REF 72413575 - batch #21FM24289
- REF 72413570 - batch #21GM04743.
Distribution
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