Extremity Medical Recalls IO FiX X-Post Reamer Due to Intraoperative Breakage
Extremity Medical LLC is recalling 156 units of the IO FiX X-Post Reamer after reports of the device breaking 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device that broke during surgery, which constitutes a significant injury risk and aligns with the 'Severe' criteria for structural defects or significant injury reports.
Plain-English summary
Extremity Medical LLC is recalling 156 units of the IO FiX X-Post Reamer, an accessory used for reaming bone in orthopedic surgical procedures. The recall was initiated after Product Event Reports indicated that a broken reamer was experienced intra-operatively. The source text notes that pre-drilling was not performed prior to reaming in the reported incidents.
The affected products were distributed worldwide, including in the United States and Switzerland. Specific U.S. states listed include Florida, Massachusetts, North Carolina, California, Maryland, Virginia, Indiana, Alabama, New Jersey, Arizona, Oklahoma, Montana, New York, Ohio, Iowa, Michigan, Texas, Wisconsin, Georgia, Illinois, Tennessee, and Nebraska. The recall involves specific catalog and lot numbers: 118-0005:126564, 118-30016:127375, 118-30018:AP6A08, and 118-30020:AP6A07.
Healthcare providers and consumers should stop using the affected reamers and contact Extremity Medical LLC for further instructions. Customer service can be reached at 888.499.0079 or via the company website at www.extremitymedical.com.
The recalled product
- Product
- IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
- Manufacturer
- Extremity Medical LLC
- Affected units
- 156
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 (3)
- 118-30016:127375
- 118-30018:AP6A08
- 118-30020:AP6A07.
Distribution
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