Stryker INFINITY Resect Guide Recalled for Incorrect Color Coding
Wright Medical is recalling 35 units of the Stryker INFINITY Resect Guide for INBONE Talus (Model #33620254) due to incorrect color coding. The color coding error could lead to misidentification and improper use during ankle 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 an FDA Class II recall for a color-coding identification error on a surgical instrument. No injuries or complications have been reported. The rubric categorizes risk-of-harm products where injury has not yet been reported as score 3 (High).
Plain-English summary
Wright Medical Technology, Inc. is recalling 35 units of the Stryker INFINITY Resect Guide for INBONE Talus, Size 4 (Model #33620254, Lot #2039558). This non-sterile surgical instrument is used with the INFINITY Total Ankle System.
The instrument is color coded incorrectly, which could result in misidentification and improper assembly or use during surgical procedures. No injuries or complications have been reported.
The recalled units were distributed nationwide in the United States in Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, Texas, and Washington. International distribution includes Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and the United Kingdom.
Those affected by this recall, including healthcare facilities and providers, should contact Wright Medical Technology for information regarding return or replacement of the recalled units.
The recalled product
- Product
- Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 35
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 #2039558
- GTIN 00889797006552.
Distribution
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